Clinical trial · Observational
First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)
Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)
NCT07679061CI-TRIAL-00116406recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab plus ipilimumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Nivolumab plus ipilimumab cohort
- description
- Participants with unresectable hepatocellular carcinoma receiving nivolumab plus ipilimumab as first-line systemic therapy in routine clinical practice in Japan.
- interventionNames
- Combination Product: Nivolumab plus ipilimumab
Primary outcomes (12)
- measure
- Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
- timeFrame
- Up to 2 years
- description
- Number of participants who experience grade 3-5 immune-mediated liver injury (IMLI), defined as treatment-related hepatic adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- measure
- Time to onset of immune-mediated liver injury (IMLI)
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.