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Recruiting NCT07679061

First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)

— Observational Unresectable Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab plus ipilimumab.
Who it may be relevant to
Registry conditions: Unresectable Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)

Overview

This study looks at how a combination of two medicines, nivolumab and ipilimumab, is used to treat people with advanced liver cancer that cannot be removed by surgery. The study will follow adults receiving this treatment in routine medical care in Japan to understand how safe it is, how well it works, and how it is used in standard clinical practice.

Interventions

  • Combination product Nivolumab plus ipilimumab
    According to product label

Primary outcome measures

  • Number of participants with grade ≥3 immune-mediated liver injury (IMLI) [Time frame: Up to 2 years]
  • Time to onset of immune-mediated liver injury (IMLI) [Time frame: Up to 2 years]
  • Time to resolution of immune-mediated liver injury (IMLI) [Time frame: Up to 2 years]
  • Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae) [Time frame: Up to 2 years]
  • Treatment prescribed to participants for immune-mediated liver injury (IMLI) [Time frame: Up to 2 years]
  • Objective response rate (ORR) [Time frame: Up to 2 years]
  • Best overall response (BOR) [Time frame: Up to 2 years]
  • Disease control rate (DCR [Time frame: Up to 2 years]
  • Duration of nivolumab plus ipilimumab combination therapy [Time frame: Up to 2 years]
  • Number of nivolumab plus ipilimumab treatment cycles per participant [Time frame: Up to 2 years]
Secondary outcome measures (12)
  • Number of participants with immune-mediated adverse events (IMAEs) [Time frame: Up to 2 years]
  • Time to onset of immune-mediated adverse events (IMAEs) [Time frame: Up to 2 years]
  • Time to resolution of immune-mediated adverse events (IMAEs) [Time frame: Up to 2 years]
  • Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae) [Time frame: Up to 2 years]
  • Treatment prescribed to participants for immune-mediated adverse events (IMAEs) [Time frame: Up to 2 years]
  • Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation [Time frame: Up to 2 years]
  • Number of participants with treatment-related adverse events (TRAEs) [Time frame: Up to 2 years]
  • Time to onset of treatment-related adverse events (TRAEs) [Time frame: Up to 2 years]
  • Time to resolution of treatment-related adverse events (TRAEs) [Time frame: Up to 2 years]
  • Number of participants with treatment-related adverse events (TRAEs) who achieve resolution (recovered, recovering, or recovered with sequelae) [Time frame: Up to 2 years]
  • Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation [Time frame: Up to 2 years]
  • Duration of response (DOR) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Participants aged ≥ 18 years at the time of consent
  • Participants with unresectable hepatocellular carcinoma (uHCC), defined as disease not eligible for curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies
  • Child-Pugh class A (total score 5-6)
  • Participants who have not received prior systemic drug therapy for uHCC
  • Participants who relapsed more than 6 months after completion of postoperative adjuvant therapy are eligible
  • Participants who received lenvatinib in combination with transarterial chemoembolization (TACE) are eligible if the treating physician determined they were eligible for TACE; participants are excluded if TACE eligibility at the time of lenvatinib initiation is unclear
  • Participants scheduled to initiate nivolumab plus ipilimumab combination therapy between March 1, 2026 and February 28, 2027
  • Nivolumab plus ipilimumab combination therapy is defined as nivolumab 80 mg and ipilimumab 3 mg/kg administered intravenously every 3 weeks for 4 cycles, followed by nivolumab monotherapy at 240 mg every 2 weeks or 480 mg every 4 weeks
  • Participants who provide written informed consent prior to initiation of nivolumab plus ipilimumab therapy

Exclusion criteria

  • Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma
  • Prior liver transplant
  • ECOG performance status ≥ 3
  • Uncontrolled comorbidities despite treatment
  • Other advanced cancers requiring systemic therapy
  • Prior immuno-oncology treatment
  • Participation in interventional clinical trials at enrollment
  • Deemed unsuitable by investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 2 centers
  • Mebix. Inc — Minato-ku
  • National Cancer Center Hospital East — Chiba

Identifiers

NCT: NCT07679061 · CA209-1554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗