{
    "info": {
        "nct_id": "NCT05612191",
        "official_title": "An Open Label Post-Trial Access (PTA) of Catequentinib (AL3818, Anlotinib) Hydrochloride Mono or in Combination Therapies in Patients Who Have Completed an Advenchen Sponsored Oncology Study With AL3818 (A Compassionate Use Trial)",
        "inclusion_criteria": "* Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients.\n* Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818.\n* Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug.\n* Patient is willing and able to sign a new informed consent.\n* Patients for whom the Investigator believes can benefit from continuing to receive AL3818\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial.\n* Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must be currently receiving treatment with AL3818 on a previously approved parent protocol, including drug crossover patients.",
            "criterions": [
                {
                    "exact_snippets": "currently receiving treatment with AL3818",
                    "criterion": "treatment with AL3818",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on a previously approved parent protocol",
                    "criterion": "previously approved parent protocol",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including drug crossover patients",
                    "criterion": "drug crossover status",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment. If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have achieved stable disease, partial response or complete response based on the most recent tumor assessment.",
                    "criterion": "tumor response",
                    "requirements": [
                        {
                            "requirement_type": "response type",
                            "expected_value": [
                                "stable disease",
                                "partial response",
                                "complete response"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "If progressive disease on the most recent tumor assessment, the Investigator believes the patient can clinically benefit from continuing to receive AL3818.",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "investigator belief",
                            "expected_value": "can clinically benefit from continuing to receive AL3818"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female patients of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug.",
            "criterions": [
                {
                    "exact_snippets": "Female patients of child-bearing potential",
                    "criterion": "female patients of child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male partners must consent to use a medically acceptable method of contraception",
                    "criterion": "male partners' consent for contraception",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of either study drug",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the study period and for 4 months after the last dose of either study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is willing and able to sign a new informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patient is willing ... to sign a new informed consent.",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient is ... able to sign a new informed consent.",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients for whom the Investigator believes can benefit from continuing to receive AL3818",
            "criterions": [
                {
                    "exact_snippets": "Patients for whom the Investigator believes can benefit from continuing to receive AL3818",
                    "criterion": "benefit from AL3818",
                    "requirements": [
                        {
                            "requirement_type": "investigator belief",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient has been discontinued from their previous AL3818 trial treatment greater than 3 weeks (one cycle) prior to entering the compassionate use trial.",
            "criterions": [
                {
                    "exact_snippets": "Patient has been discontinued from their previous AL3818 trial treatment",
                    "criterion": "discontinuation from previous AL3818 trial treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "greater than 3 weeks (one cycle) prior to entering the compassionate use trial",
                    "criterion": "time since discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818.",
            "criterions": [
                {
                    "exact_snippets": "Patient progressed while receiving therapy with AL3818 during their participation in their immediate previous trial",
                    "criterion": "progression on AL3818",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the Investigator believes the patient can clinically benefit from continuing to receive AL3818",
                    "criterion": "clinical benefit from AL3818",
                    "requirements": [
                        {
                            "requirement_type": "investigator belief",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}