{
    "info": {
        "nct_id": "NCT06390982",
        "official_title": "A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer：the RELIEVE-01 Study",
        "inclusion_criteria": "1. Able to provide written informed consent, understand and comply with the requirements and evaluation schedule\n2. ≥18, ≤75 years old\n3. Histologically confirmed rectal adenocarcinoma\n4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS\n5. The distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or MRI\n6. clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)\n7. Resectable primary tumor assessed by the Investigator\n8. Have not received any anti-tumor treatment for rectal cancer\n9. ECOG PS ≤ 1\n10. Adequate organ function\n11. Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma\n2. Have received any treatments for rectal cancer, or evidence of distant metastasis\n3. Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d\n4. Presence or in high risk of obstruction, perforation or bleeding;\n5. Not suitable for long-course radiotherapy\n6. Cannot tolerate surgery\n7. ≥2 colorectal cancer lesions at the same time\n8. Contraindications for MRI examination\n9. Other malignant tumors in the past or at the same time\n10. Have an active autoimmune disease requiring systemic therapy within the past 2 years\n11. HIV infection\n12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA > 500 IU/mL) or active HCV carriers with detectable HCV RNA;\n13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container\n14. Other conditions judged by the researcher that do not meet the enrollment requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Able to provide written informed consent, understand and comply with the requirements and evaluation schedule",
            "criterions": [
                {
                    "exact_snippets": "Able to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "understand and comply with the requirements and evaluation schedule",
                    "criterion": "compliance with requirements and evaluation schedule",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ≥18, ≤75 years old",
            "criterions": [
                {
                    "exact_snippets": "≥18, ≤75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed rectal adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed rectal adenocarcinoma",
                    "criterion": "rectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS",
            "criterions": [
                {
                    "exact_snippets": "immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2)",
                    "criterion": "pMMR status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "immunohistochemistry"
                        },
                        {
                            "requirement_type": "gene positivity",
                            "expected_value": [
                                "MLH1",
                                "MSH2",
                                "MSH6",
                                "PMS2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "PCR /NGS confirmed MSI-L or MSS",
                    "criterion": "MSI status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "PCR",
                                "NGS"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "MSI-L",
                                "MSS"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or MRI",
            "criterions": [
                {
                    "exact_snippets": "distance from the lower edge of the tumor to the anal verge is ≤5 cm",
                    "criterion": "distance from the lower edge of the tumor to the anal verge",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)",
            "criterions": [
                {
                    "exact_snippets": "clinical stage cT1-3N1M0 or cT2-3N0M0",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "cT1-3N1M0",
                                "cT2-3N0M0"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "T and N is evaluated by MRI",
                    "criterion": "T and N evaluation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "MRI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Resectable primary tumor assessed by the Investigator",
            "criterions": [
                {
                    "exact_snippets": "Resectable primary tumor",
                    "criterion": "primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "assessed by the Investigator",
                    "criterion": "assessment by Investigator",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Have not received any anti-tumor treatment for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "Have not received any anti-tumor treatment for rectal cancer",
                    "criterion": "anti-tumor treatment for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. ECOG PS ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate organ function",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects with the ability to become pregnant",
                    "criterion": "female subjects",
                    "requirements": [
                        {
                            "requirement_type": "ability to become pregnant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum pregnancy test with a negative result within 72 hours before the first dose",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours before the first dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use highly effective contraceptive methods during the trial and 120 days after the last dose",
                    "criterion": "contraceptive methods",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and 120 days after the last dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male subjects whose partners are women of childbearing potential",
                    "criterion": "male subjects",
                    "requirements": [
                        {
                            "requirement_type": "partner's childbearing potential",
                            "expected_value": "women of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose",
                    "criterion": "contraception for male subjects",
                    "requirements": [
                        {
                            "requirement_type": "surgical sterilization",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "agreement to use contraception",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and for 120 days after the last dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "differentiation",
                            "expected_value": [
                                "poorly differentiated",
                                "undifferentiated"
                            ]
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "mucinous adenocarcinoma",
                    "criterion": "mucinous adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signet ring cell carcinoma",
                    "criterion": "signet ring cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have received any treatments for rectal cancer, or evidence of distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "Have received any treatments for rectal cancer",
                    "criterion": "treatment for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d",
            "criterions": [
                {
                    "exact_snippets": "Presence of following high risk factors assessed by MRI: MRF +",
                    "criterion": "MRF",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of following high risk factors assessed by MRI: ... EMVI+",
                    "criterion": "EMVI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of following high risk factors assessed by MRI: ... cN2",
                    "criterion": "cN2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of following high risk factors assessed by MRI: ... Positive lateral lymph nodes",
                    "criterion": "lateral lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of following high risk factors assessed by MRI: ... T3d",
                    "criterion": "T3d",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Presence or in high risk of obstruction, perforation or bleeding;",
            "criterions": [
                {
                    "exact_snippets": "Presence or in high risk of obstruction",
                    "criterion": "obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence or in high risk of ... perforation",
                    "criterion": "perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence or in high risk of ... bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Not suitable for long-course radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Not suitable for long-course radiotherapy",
                    "criterion": "suitability for long-course radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Cannot tolerate surgery",
            "criterions": [
                {
                    "exact_snippets": "Cannot tolerate surgery",
                    "criterion": "surgery tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ≥2 colorectal cancer lesions at the same time",
            "criterions": [
                {
                    "exact_snippets": "≥2 colorectal cancer lesions",
                    "criterion": "colorectal cancer lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Contraindications for MRI examination",
            "criterions": [
                {
                    "exact_snippets": "Contraindications for MRI examination",
                    "criterion": "MRI examination",
                    "requirements": [
                        {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Other malignant tumors in the past or at the same time",
            "criterions": [
                {
                    "exact_snippets": "Other malignant tumors in the past",
                    "criterion": "malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "past"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other malignant tumors ... at the same time",
                    "criterion": "malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "present"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Have an active autoimmune disease requiring systemic therapy within the past 2 years",
            "criterions": [
                {
                    "exact_snippets": "active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 2 years",
                    "criterion": "time since last systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. HIV infection",
            "criterions": [
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA &amp;gt; 500 IU/mL) or active HCV carriers with detectable HCV RNA;",
            "criterions": [
                {
                    "exact_snippets": "Untreated chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic hepatitis B virus (HBV) carriers",
                    "criterion": "chronic hepatitis B virus carriers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV DNA &amp;gt; 500 IU/mL",
                    "criterion": "HBV DNA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 500,
                                "unit": "IU/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active HCV carriers",
                    "criterion": "active HCV carriers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable HCV RNA",
                    "criterion": "HCV RNA",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity to any ingredient of tislelizumab",
                    "criterion": "hypersensitivity to tislelizumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to any ingredient of ... capecitabine",
                    "criterion": "hypersensitivity to capecitabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to any ingredient of ... oxaliplatin",
                    "criterion": "hypersensitivity to oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity ... to any component of the container",
                    "criterion": "hypersensitivity to container components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Other conditions judged by the researcher that do not meet the enrollment requirements",
            "criterions": [
                {
                    "exact_snippets": "Other conditions judged by the researcher that do not meet the enrollment requirements",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "do not meet the enrollment requirements"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}