More than 5 discrete intrahepatic parenchymal foci of definite HCC
Measureable common or main branch biliary duct involvement with HCC
For HCC:
Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Participants previously receiving any prior therapy for HCC, including loco-regional therapies
HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
Patients must have HCC limited to the liver; there must be no definitive clinical or radiographic evidence of extrahepatic HCC; portal lymphadenopathy is permitted as lymphadenopathy is commonly associated with cirrhosis unrelated to malignancy
Patients with locally advanced HCC not eligible for curative therapies
Patient who has received previous systemic therapy or transarterial chemoembolization (TACE) for HCC
Have a diagnosis of hepatocellular carcinoma (HCC) and high risk for HCC recurrence
Concurrent administration of systemic therapy for HCC
No prior systemic therapy for HCC
Histology and/or cytology confirmed HCC per the enrolling institution; subjects in Cohort 1 are permitted to enroll without confirmation of HCC as long as imaging Liver Imaging Reporting and Data System (LiRAD)s criteria are met and a biopsy is scheduled prior to or the day of the deb-TACE procedure; HCC confirmation must be completed prior to initiation of nivolumab for all cohorts; if a patient is found to not have confirmed HCC, they will be removed from the study
Patient must have a histologically confirmed diagnosis hepatocellular carcinoma; known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC will be excluded
Patient who has received previous systemic therapy for HCC
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Any prior systemic therapy for HCC
Known fibrolamellar or mixed HCC-cholangiocarcinoma histology
Confirmed HCC based on histopathological findings from tumor tissues. Unresectable HCC with diagnosis confirmed pathologically or with noninvasive methods.
Fibrolamellar carcinoma or mixed HCC
Patients must have no prior history of treatment for HCC (treatment naive).
Patients must not have received prior anticancer therapy with anti-CLTA-4 or anti-PD1 for HCC. Patients receiving any concomitant systemic therapy for HCC are excluded
Prior systemic therapies for HCC are allowed but not required
Patients within unresectable HCC
Patients with resectable HCC
Histological or radiologic diagnosis of advanced (unresectable or metastatic) HCC with Child-Pugh A or Child Pugh B7 cirrhosis:\r\n* The diagnosis of HCC will be made according to the European Association for the Study of the Liver-European Organization for Research and Treatment of Cancer Clinical Practice Guidelines (EASL–EORTC CPG) and according to successive modifications of the American Association for the Study of Liver Disease (AASLD) practice guidelines \r\n* Pathological diagnoses of HCC will be made according to the International Working Party criteria
Cytologically or histologically confirmed advanced or metastatic HCC; if no histological diagnosis, patient must have imaging studies compatible with HCC
Measurable common or main branch biliary duct involvement with HCC
More than one line of prior systemic therapy for HCC
No prior treatment of current HCC; however, recurrent HCC after resection may be included
Subjects who have radiographic or histological diagnosis of hepatocellular cancer (HCC), with advanced stage disease that is not amenable to curative surgical resection; patients without histologic diagnosis must meet the radiographic criteria for HCC
Histological or radiologic confirmation of advanced or metastatic HCC:\r\n* The diagnosis of HCC will be made according to the guidelines of the Barcelona-2000 European Association for the Study of the Liver (EASL) Conference (Bruix et al 2001) and according to successive modifications of the American Association for the Study of Liver Disease (AASLD) (Bruix et al 2005) \r\n* Pathological diagnoses of HCC will be made according to the International Working Party criteria (International Working Party 1995)
Diagnosis of HCC:
HCC is advanced, ie, treatment-refractory or metastatic, and no standard therapies are expected to be curative.
Receipt of no, or of >1, prior systemic drug therapies for HCC.
Active malignancy other than HCC.
Subjects not meeting the AASLD criteria for HCC will need a biopsy to confirm HCC prior to randomization.
Have previously received therapeutic treatment for HCC outside the study protocol or is expected to receive concomitant HCC treatment prior to PFS event.
Unilobar HCC
Pathologically newly diagnosis HCC, which is deemed resectable and resected
No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
Patients with advanced HCC not amenable for surgical or loco-regional treatment
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Subjects who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.
Histological or cytological confirmation of HCC (hepatocellular carcinoma) or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
Diagnosis of liver-only HCC based on European Association for the Study of the Liver (EASL) criteria (radiographic lesion appearance on contrast-enhanced computed tomography [CT] or magnetic resonance imaging [MRI], i.e. enhancement on early arterial phase, washout on portal venous phase with or without associated elevation of serum AFP level > 200 U/ml) or histologic confirmation of HCC diagnosis, whichever is applicable
Patients must have histologically diagnosed American Joint Committee on Cancer (AJCC) stage II, III, or IV HCC not eligible for curative resection, transplantation, or ablative therapies\r\n* Cases with mixed, composite, or combined HCC-cholangiocarcinoma histology are eligible with approval from study chair and provided the treating investigator believes it is in the best interest of the patient to treat the tumor with therapy targeted towards the HCC component of tumor based upon review of pathology and clinical\r\ncharacteristics
Biliary tract cancers or fibrolamellar variant tumors are excluded\r\n* Cases with mixed, composite, or combined HCC-cholangiocarcinoma histology are eligible with approval from study chair and provided the treating investigator believes it is in the best interest of the patient to treat the tumor with therapy targeted towards the HCC component of tumor based upon review of pathology and clinical characteristics
Prior systemic cytotoxic therapies for HCC (chemoembolization is permitted if inclusion criteria are met)
Patients must have hepatocellular carcinoma (HCC) with one of the following: \r\n* Microvascular/macrovascular invasion, \r\n* Tumor outside of Milan criteria, \r\n* Poor tumor differentiation; \r\n* Elevated surrogate markers (AFP > 500 or PIVKA [DCP] > 400) pre transplant and with biopsy proven HCC prior to orthotopic liver transplantation (OLT) or on explants
Patients with local lymph node metastases\r\n* However, patients with high risk HCC who have been down-staged prior to OLT and show 100% necrosis on explant are eligible as long as there is biopsy proven HCC
Patients with fibrolamellar HCC, cholangiocarcinoma, and combined HCC-cholangiocarcinoma
Prior use of systemic investigational agents for HCC
Phase 2 expansion: HCC
Progression following at least 1 prior systemic treatment for HCC.
Receipt of more than 2 prior systemic therapies for advanced HCC.
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Participants with HCC that:
Have known HCC with fibro-lamellar or mixed histology.
Unresectable HCC confirmed by histology or by non-invasive AASLD criteria
Participants with diagnosis of HCC.
Subjects must have confirmed diagnosis of unresectable HCC with any of the following criteria:
Imaging findings for HCC corresponding to any of the following:
HCC with greater than or equal to 50 percent liver occupation
Advanced tumoral disease, defined as vascular invasion, extrahepatic spread, or diffuse HCC (50% liver involvement)
Subject has a documented diagnosis of advanced HCC of any etiology.
Subject has fibrolamellar variant of HCC.
Subject has a history of a non-HCC malignancy with the following exceptions:
Part A2 only: Patients with histological or cytological diagnosis of HCC who have had 0 to 2 prior lines of systemic therapy (progressed or intolerant to approved HCC standard of care treatment).
No prior systemic therapy for HCC
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Diagnosis of hepatocellular carcinoma (HCC) confirmed histologically, excluding mixed HCC histology (e.g. HCC plus cholangiocarcinoma) or fibrolamellar variant
Advanced staged HCC (unresectable and not amenable to local or regional therapy; or metastatic HCC); the diagnosis of HCC should be based on at least one of the following:\r\n* Magnetic resonance imaging (MRI) or computed tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion measuring >= 2 cm, with characteristics arterial enhancement and venous washout regardless of alpha-fetoprotein (AFP) levels\r\n* AFP >= 400 ng/mL AND evidence of at least one solid liver lesion >= 2 cm regardless of specific imaging characteristics on CT or MRI\r\n* Histological/cytology biopsy confirming HCC
Histologically confirmed advanced HCC
No prior systemic regimens for HCC
Histological or cytological confirmation of HCC (hepatocellular carcinoma) or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases criteria in patients with a confirmed diagnosis of cirrhosis
Known to be Hepatitis B or C positive (except HCC patients)
Have histological evidence of a diagnosis of HCC not amenable to curative surgery
Known HCC with fibro-lamellar or mixed histology
Diagnosis of HCC
Diagnosis of HCC
Locally advanced HCC
Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC.
Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
Documented complete response to HCC treatment.
Diagnosis of fibrolamellar HCC or tumors of mixed histology.
Confirmed to have HCC as described by the American Association for the Study of Liver Disease (AASLD).
Histologically confirmed HCC
Histologically confirmed diagnosis of advanced solid tumor (dose escalation component) or metastatic melanoma (uveal or cutaneous) (doses escalation and MTD expansion components) or platinum-resistant (tumor progression within a year after the completion of platinum-based therapy) ovarian carcinoma (high grade serous, endometrial or poorly differentiated endometrioid) or HCC that has failed treatment with sorafenib or did not tolerate sorafenib or refused sorafenib, or HCC with coexistent BCT that has or has not been treated with chemotherapy, or BCT that has or has not been treated with chemotherapy. For HCC and HCC with coexistent BCT, cirrhotic status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix C). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.
Ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status to be performed retrospectively for the ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only cohorts. Subjects with no tissue available would require a biopsy.
Fibrolamellar histology HCC, mixed hepatocholangiocarcinoma, hepatic sarcomas and other non-HCC primary liver tumors
First line advanced HCC (i.e., no prior systemic therapy)
HCC diagnosed by tissue or imaging study
Unresectable HCC without extrahepatic disease based on CT
No prior systemic therapy for HCC
Patients with hepatocellular carcinoma (HCC) are eligible for this trial; HCC is defined as having at least one of the following:\r\n* HCC diagnosed either on biopsy or based on standard imaging criteria on contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) (arterial enhancement with washout and pseudocapsule); or\r\n* A discrete hepatic tumor(s) as defined by the Barcelona criteria for cirrhotic patients, > 1 centimeter (cm) with arterial hypervascularity and venous or delayed phase washout on CT or MRI\r\n* Presentation at multidisciplinary liver tumor board to assess eligibility for either SBRT or MWA
The foci of HCC must be in an anatomic location amendable to treatment by both MWA and SBRT
Patients with 3 or more foci of HCC
Participants with advanced or metastatic and/or unresectable HCC
A diagnosis of HCC based on histopathologic findings, or a diagnosis of cirrhosis and a tumor with classical HCC imaging characteristics.
Participant has confirmed HCC by CT/MRI; participants who have previously had HCC but have been treated and have been recurrence free for 5 years are eligible
Have an HCC mass viewable on grayscale B-mode ultrasound
Patients not eligible or scheduled for TACE of a HCC mass
Patients with a known infiltrative variant of HCC
Patients diagnosed with HCC, who will undergo resection or transplantation within 6 months, as part of routine clinical care and patients diagnosed with unresectable HCC
HCC PATIENTS: Patient with confirmed diagnosis of HCC, and untreated or
HCC PATIENTS: Patients with suspected HCC (suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or
HCC PATIENTS: Patients at a higher risk of HCC undergoing a screening program by ultrasound
Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging
Cohort A: HCC with FGF19 amplification.
Cohort B: HCC without FGF19 amplification.
Histologically confirmed HCC, not amenable to transplant, resection or loco-regional therapy
Other active malignancy besides HCC within 3 years.
Must be listed for liver transplantation with HCC exception points based on the imaging diagnosis of at least one Organ Procurement and Transplantation Network (OPTN) class 5 HCC lesion(s) per study-defined imaging criteria (participating institutions may not enroll patients in whom the HCC diagnosis is solely based on biopsy and who do not have at least one liver lesion that meets imaging criteria for OPTN Stage 2, Class 5 HCC)\r\n* Patients must meet one of the following descriptions based on imaging findings:\r\n** EITHER OPTN Class 5B: at least 1 focal liver lesion(s) >= 2 cm diameter compatible with imaging diagnosis of Stage II HCC on contrast-enhanced CT imaging and/or contrast-enhanced MRI;\r\n** OR OPTN Class 5A: 2 or 3 focal liver lesions, each between > 1 and < 3 cm diameter, if each is compatible with imaging diagnosis of HCC on contrast-enhanced CT imaging and/or contrast-enhanced MRI\r\n** Imaging findings at the patient level in both situations must be within the United Network for Organ Sharing (UNOS) Stage 2, which is Milan criteria
Does not meet OPTN Class 5 imaging criteria for HCC, even if they have biopsy-proven HCC; NOTE: Patients enrolled to the trial under the “Declaration of Intent to List” mechanism who fail to be listed with HCC MELD/PELD Score Exception history data on the UNOS UNET Web site within 60 days from enrollment will come off trial and will not be counted towards target accrual
Subjects who have received prior treatment for HCC (prior surgical procedures not related to HCC are allowed)
History of HCC or suspicious mass on imaging within 6 months prior to ascertainment of eligibility
HCC screening prior to randomization
Maximal diameter of any one hepatocellular carcinoma > 15 cm
Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)
Patients must have confirmed hepatocellular carcinoma (HCC) by histopathology or imaging criteria according to AASLD guidelines.
Confirmed diagnosis of hepatocellular carcinoma (HCC)
Subjects must have a diagnosis of measurable advanced or metastatic hepatocellular carcinoma; advanced HCC is defined as disease not amenable to surgery, ablation, transplant, or embolic therapy
Histologically confirmed diagnosis of hepatocellular carcinoma (mixed HCC/cholangiocarcinoma is allowed)
Hepatocellular carcinoma;
HCC (unresectable hepatocellular carcinoma) histopathological diagnosis confirmation based on tumor tissue
Confirmed hepatocellular carcinoma (HCC) by one of the following: \r\n* Histopathology\r\n* One radiographic technique that confirms a lesion >= 1 cm with arterial hypervascularization with washout on delayed phase
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Patients with hepatocellular carcinoma do not need to have histologic confirmation of disease as long as they meet the radiologic criteria for diagnosis of hepatocellular carcinoma (HCC) (evidence of arterial phase enhancement with corresponding venous or delayed phase wash out)
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Patients must have advanced disease that is not amenable for resection or transplantation, and that is not treatable with liver directed modalities such as radiofrequency ablation or transarterial chemoembolization
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Patients are not required to have failed sorafenib
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Ascites that is not medically controlled or that required a therapeutic paracentesis within last 3 months
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Any episode of hepatic encephalopathy within the previous 6 months
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Variceal bleeding within last 6 months
Histologically or cytologically confirmed hepatocellular carcinoma or biliary tract cancer.
Progressed on, be intolerant of, or refused sorafenib (for hepatocellular carcinoma [HCC]), second line treatment and beyond for cholangiocarcinoma or gemcitabine-based chemotherapy for biliary tract cancer.
Histologic or cytologic diagnosis of unresectable, locally advanced and/or metastatic hepatocellular carcinoma (HCC) not amenable to curative surgery, transplantation, or ablative therapies based upon assessment of treating investigator
Confirmed unresectable or metastatic hepatocellular carcinoma; confirmation either by histologic confirmation or accepted radiographic criteria
Diagnosis of primary liver malignancy including hepatocellular carcinoma (HCC) or cholangiocarcinoma by characteristic imaging findings on computed tomography (CT) or MRI, clinical presentation, and/or pathologic confirmation of diagnosis; subjects with other current or prior malignancies are eligible for this study
Diagnosis of hepatocellular carcinoma
Pathologic diagnosis of hepatocellular carcinoma (including fibrolamellar variants and biphenotypic tumors with a hepatocellular carcinoma [HCC] component)
Patients with diagnoses of hepatocellular carcinoma (HCC) according to European Association for the Study of Liver disease (EASL) criteria for diagnosis; regional lymphadenopathy will be allowed\r\n* Any virus status accepted (e.g. hepatitis C, etc.)\r\n* Any prior liver treatment
Colorectal, hepatocellular, gallbladder, cholangiocarcinoma, neuroendocrine, melanomas, hematological and central nervous system (CNS) malignancies;
Presence of primary hepatobiliary malignancy, including cholangiocarcinoma or hepatocellular carcinoma, gallbladder carcinoma, cancer of ampulla of Vater.
Advanced, unresectable hepatocellular carcinoma (unsuitable for resection, transplant or ablation)
Any one hepatocellular carcinoma > 15 cm
Total maximal sum of hepatocellular carcinomas or a single conglomerate HCC > 20 cm
Subjects with advanced hepatocellular carcinoma (HCC) with no curative option
Patient must have advanced hepatocellular carcinoma; fibrolamellar HCC is not allowed; hepatocellular carcinoma should be confirmed by at least one of the following:\r\n* Tissue diagnosis\r\n* The presence of one or more liver lesions measuring >= 2 cm in longest diameter, showing characteristic arterial enhancement and venous washout using arterial-phase contrast enhanced imaging, and a clinical history of cirrhosis
Diagnosis of hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis from any histology
Part 2 Group B is restricted to HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:\r\n* Histologically confirmed\r\n* Magnetic resonance imaging (MRI) or computerized tomography (CT) findings consistent with hepatocellular carcinoma\r\n* Alpha fetoprotein (AFP) > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI
Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required
Patients must have a diagnosis of hepatocellular carcinoma confirmed by at least one of the following: \r\n* Histological confirmation; \r\n* Imaging results consistent with cirrhosis and at least one solid liver lesion of > 2 cm with early enhancement and delayed washout (American Association for the Study of Liver Diseases [AASLD] criteria for diagnosis of hepatocellular carcinoma [HCC]);\r\n* Alpha fetoprotein level > 400 ng/mL and evidence of at least one solid liver lesion > 2 cm, regardless of specific imaging characteristics on magnetic resonance imaging (MRI)
Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods\r\n* Pathologically confirmed hepatocellular carcinoma (HCC) by biopsy, OR\r\n* HCC > 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced magnetic resonance imaging (MRI) or computed tomography (CT), OR\r\n* Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alpha fetoprotein (AFP) greater than 200 ng/mL
Patient diagnosed with hepatocellular carcinoma and listed for orthotopic liver transplantation at the participating institution in accordance with Organ Procurement and Transplantation Network (OPTN) guidelines
Patients with hepatocellular carcinoma will be excluded from this study
Subjects with hepatocellular carcinoma must have received sorafenib as one of the standard treatment options prior to being enrolled into the study
Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) Guidelines.
Subject has received more than 2 previous systemic therapies for Hepatocellular carcinoma (HCC).
Pathologically (histologically or cytologically) or radiographically-proven (based on the American Association for the Study of Liver Diseases [AALSD] criteria) unresectable or locally recurrent hepatocellular cancer prior to registration
Patients with hepatocellular carcinoma are eligible for this trial; hepatocellular carcinoma is defined as having at least one of the following:\r\n* Biopsy proven hepatocellular carcinoma (HCC); or\r\n* A discrete hepatic tumor(s) as defined by the Barcelona criteria – for cirrhotic patients, > 1 cm with arterial hypervascularity and venous or delayed phase washout on computed tomography (CT) or MRI
If the patient is determined to be cirrhotic (based on criteria outlined earlier), the patient must have an ultrasound done within 6 months prior to enrollment with no evidence of hepatocellular carcinoma
Has a HCC diagnosis confirmed by radiology, histology or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
Must have histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
Chronic hepatitis (except for subjects with hepatocellular carcinoma)
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
Hepatocellular carcinoma (HCC)\r\n* Not eligible for curative attempt resection or liver transplant
Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
Cohort 2: Participants must have hepatocellular carcinoma (HCC). These participants should have Child-Pugh stage A.
Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
Patients with hepatocellular carcinoma may be eligible provided they have AST and ALT that are ? 5.0 x ULN.
Platelets ? 100 x 10^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count ? 75 x 10^9/L.
Have mixed hepatocellular biliary tract cancer histology.
For Cohort 1: has histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) based on pathology report
For Cohort 2: has an HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)
Platelets ? 100 x 10^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count ? 75 x 10^9/L.
Patients with the diagnosis of hepatocellular carcinoma (HCC) currently being evaluated for liver transplantation and considered for downstaging
History of recurrent bacterial infections unrelated to hepatocellular carcinoma (HCC) (particularly skin or lung)
Hepatocellular carcinoma for which treatment with FOLFOX6 or CAPOX would be acceptable as determined by the Investigator.
Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
Histologically/cytologically verified, non-resectable, recurrent, or metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma; combined cholangiocarcinoma and hepatocellular carcinoma is allowed
Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma according to the American Association for the Study of Liver Diseases Guidelines.A biopsy performed at screening may serve as a diagnostic biopsy for subjects with radiographic diagnosis.
Histologic diagnosis of liver-confined fibrolamellar or non-fibrolamellar hepatocellular carcinoma (HCC)
Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis (confirmed by non-invasive criteria EASL/AASLD, mandatory by histology in non-cirrhotic patients); can be naive or recurrent HCC after curative treatment (> 6 months before randomization)
Patients (except those with hepatocellular carcinoma) must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor or lymphoma that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective; patients with hepatocellular carcinoma do not require biopsy confirmation; a liver mass with raised alpha-fetoprotein level (>= 500 ng/mL), consistent radiographic changes, and serology and viral deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) measurements consistent with chronic hepatitis will be sufficient to identify hepatocellular carcinoma without the need for pathologic confirmation of the diagnosis; patients with hepatocellular carcinoma must still, however, have disease that has failed standard therapy; having chronic hepatitis B or C will not exclude patients from participating
Part B2: Hepatocellular cancer (excluding fibrolamellar carcinoma)
Subjects must have histologically or cytologically confirmed advanced solid tumor. However, Hepatocellular Carcinoma (HCC) subjects are allowed without histological confirmation as long as there is radiological diagnosis as per standard criteria
Histologically documented hepatocellular carcinoma
Histologically or cytologically confirmed hepatocellular carcinoma that is metastatic, unresectable, or recurrent.
Patients who have a diagnosis of hepatocellular carcinoma made through radiologic imaging may be eligible, provided they meet the criteria according to the American Association for the Study of Liver Disease, AASLD (Bruix and Sherman, 2005; Bruix and Sherman, 2011)
Cytological or histological confirmed diagnosis of advanced hepatocellular or renal cell carcinoma; HCC patients should not be amenable to treatment with surgery or to orthotopic liver transplant (Phase I)
Subjects with hepatocellular carcinoma
Hepatocellular Carcinoma (HCC) --Histologic or cytologic diagnosis of hepatocellular carcinoma
Patients diagnosed with hepatocellular carcinoma, or who have a history of biliary sepsis within the past 2 years
Barcelona Clinic Liver Cancer (BCLC) advanced stage (C) hepatocellular carcinoma, or BCLC intermediate stage (B) hepatocellular carcinoma if treatment with transarterial chemoembolization is not considered appropriate
PATIENT: Biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
Patients will have one of the following diseases: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver
Prior known or suspected hepatocellular carcinoma
Only participants found to express high levels (immunohistochemistry [IHC] score 3 and above) of gamma-OHPdG (gamma-OHPdG-high hepatocellular carcinoma [HCC]) in baseline liver biopsy will be enrolled to receive Polyphenon E treatment
Hepatocellular carcinoma
Patients with a diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, or metastatic liver cancer planned to receive definitive doses of radiation or surgical resection are eligible
Scheduled for TACE treatment of a hepatocellular carcinoma (HCC) mass (lesions reported as Liver Imaging Reporting and Data Systems 4B or 5 or Organ Procurement and Transplantation Network 5a or 5b)
Subjects must have a diagnosis of hepatocellular carcinoma (HCC) and a treatment plan to undergo radioembolization therapy with Y-90 at Indiana University Health Hospital
Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LI-RADS) 4 or greater
Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
Subjects must have verified unresectable hepatocellular carcinoma (HCC), diagnosed on the basis of clinical and imaging criteria
Participants must have histologically or cytologically confirmed hepatocellular carcinoma OR have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma