Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with grade ≥3 immune-mediated liver injury (IMLI)
时间窗: Up to 2 years
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.
Time to onset of immune-mediated liver injury (IMLI)
时间窗: Up to 2 years
Time from first dose of nivolumab plus ipilimumab to first occurrence of immune-mediated liver injury (any grade).
Time to resolution of immune-mediated liver injury (IMLI)
时间窗: Up to 2 years
Time from onset of immune-mediated liver injury to resolution, defined as recovery, recovery with sequelae, or improvement per clinician assessment.
Number of participants with immune-mediated liver injury (IMLI) who achieve resolution (recovered, recovering, or recovered with sequelae)
时间窗: Up to 2 years
Treatment prescribed to participants for immune-mediated liver injury (IMLI)
时间窗: Up to 2 years
Objective response rate (ORR)
时间窗: Up to 2 years
Number of participants with complete response (CR) or partial response (PR) as best overall response among participants with baseline target lesions, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Best overall response (BOR)
时间窗: Up to 2 years
Distribution of best overall response categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) among participants with baseline target lesions per RECIST v1.1.
Disease control rate (DCR
时间窗: Up to 2 years
Number of participants with complete response (CR), partial response (PR), or stable disease (SD) as best overall response among participants with baseline target lesions per RECIST v1.1.
Duration of nivolumab plus ipilimumab combination therapy
时间窗: Up to 2 years
Time from first dose of nivolumab plus ipilimumab to treatment discontinuation.
Number of nivolumab plus ipilimumab treatment cycles per participant
时间窗: Up to 2 years
Total number of administered cycles of nivolumab plus ipilimumab given every 3 weeks, summarized per participant.
Number of participants who discontinue treatment
时间窗: Up to 2 years
Number of participants who discontinue nivolumab plus ipilimumab.
Reasons for treatment discontinuation
时间窗: Up to 2 years
Distribution of reasons, including disease progression, adverse events death, participant request, transfer, or other reasons as assessed by treating clinician.
次要结局
- Treatment prescribed to participants for immune-mediated adverse events (IMAEs)(Up to 2 years)
- Number of participants with of immune-mediated adverse events (IMAEs) leading to treatment discontinuation(Up to 2 years)
- Number of participants with immune-mediated adverse events (IMAEs)(Up to 2 years)
- Time to onset of immune-mediated adverse events (IMAEs)(Up to 2 years)
- Time to resolution of immune-mediated adverse events (IMAEs)(Up to 2 years)
- Number of participants with immune-mediated adverse events (IMAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)(Up to 2 years)
- Number of participants with treatment-related adverse events (TRAEs)(Up to 2 years)
- Time to onset of treatment-related adverse events (TRAEs)(Up to 2 years)
- Time to resolution of treatment-related adverse events (TRAEs)(Up to 2 years)
- Number of participants with treatment-related adverse events (TRAEs) who achieve resolution (recovered, recovering, or recovered with sequelae)(Up to 2 years)
- Number of participants with treatment-related adverse events (TRAEs) leading to treatment discontinuation(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Overall survival (OS(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Second progression-free survival (PFS2)(Up to 2 years)
- Depth of response (DpR)(Up to 2 years)
- Change from baseline in Child-Pugh score(Up to 2 years)
- Change from baseline in albumin-bilirubin (ALBI) and modified ALBI (mALBI) grades based on laboratory values.(Up to 2 years)
- Number of participants receiving subsequent therapy(Up to 2 years)
- Type of subsequent therapy received(Up to 2 years)