Hepatocellular Carcinoma Hepatocellular Carcinoma
Conditions
Interventions
None listed
Sponsors
Sakaguchi Naoya
Fujiwara Akinori
Ono Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged more than 18 years at the time of consent 2) Patients with uHCC *1 *1 Participants must have an uHCC, defined as: i) Disease not eligible for curative surgical and/or locoregional therapies, OR ii) Progressive disease after surgical and/or locoregional therapies. 3) Classified as Child-Pugh A (total point: 5 or 6) 4) Patients who have not received systemic drug therapy for uHCC *2, *3 *2 Patients who have relapsed more than 6 months after the completion of postoperative adjuvant therapy are eligible for enrollment. *3 If the treating physician determined that a patient was eligible for transarterial chemoembolization (TACE), the patient who received lenvatinib in combination with TACE will be eligible for this study. However, if it is unclear whether the patient was eligible for TACE at the time of dosing lenvatinib, the patient will be excluded. 5) Patients who are scheduled to initiate nivolumab plus ipilimumab (NIVO+IPI) combination therapy from March 1, 2026 to February 28, 2027 *4 *4 NIVO+IPI combination therapy: The usual adult dosage is administered with 80 mg of nivolumab (NIVO) and 3 mg/kg of ipilimumab (IPI) by intravenous infusion every 3 weeks for a total of 4 cycles. After that, NIVO is administered by intravenous infusion at a dose of 240 mg every 2 weeks or 480 mg every 4 weeks. 6) Patients who have provided written consent themselves for this clinical study before initiation of NIVO+IPI combination therapy
Exclusion criteria
Exclusion criteria: 1) Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC 2) Prior liver transplant 3) Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) more than 3 4) Patients with uncontrollable comorbidities despite appropriate treatment 5) Patients with other advanced cancers*1 as comorbidities *1 Early-stage cancers that do not require systemic drug therapy for cancer are permitted. 6) Patients with a history of immuno-oncology treatment 7) Patients who are participating in interventional clinical trials at the time of enrollment 8) Patients deemed unsuitable for participation in this study by the principal investigator or attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety profile on grade 3 or higher immune-mediated liver injury (IMLI)*: incidence and resolution rates of grade 3 or higher events, time to onset and resolution, and treatment course after onset in individual patient level * IMLI is defined as liver injury that is considered immune-mediated among treatment-related adverse event (TRAE). IMLI encompasses various hepatic conditions, including acute liver failure, acute exacerbation of chronic liver failure, increased ALT, increased AST, autoimmune cholangitis, autoimmune hepatitis, biliary cirrhosis, increased blood bilirubin, cholangitis, drug-induced liver injury (DILI), liver failure, hepatitis, acute hepatitis, hepatotoxicity, hyperbilirubinemia, hypertransaminasemia, immune-mediated cholangitis, immune-mediated cholestasis, immune-mediated hepatitis, and elevated transaminases. 2) Effectiveness based on the following measures: objective response rate (ORR), best overall response (BOR) and disease control rate (DCR) 3) Treatment patterns on NIVO+IPI: patient baseline characteristics, treatment duration, number of treatment cycles, and reasons for treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety profile on immune-mediated adverse events (IMAEs)**: incidence and resolution rates, time to onset and resolution, proportion of high-dose steroid use for management of IMAEs, incidence of IMAEs leading to treatment discontinuation ** IMAE is defined as AE that is considered immune-mediated among TRAE. 2) Effectiveness: duration of response (DOR), overall survival (OS), progression-free survival (PFS), second progression-free survival (PFS2), depth of response (DpR) 3) Impact on liver function 4) Proportion and details of subsequent therapy after NIVO+IPI combination therapy | — |
Contacts
Public ContactNaoya Sakaguchi
Bristol-Myers Squibb K.K.
Outcome results
None listed