NCT07714317尚未招募1 期
Phase Ib/II Multicenter Randomized Control Study of Peri-operative Treatment With Combination of CTLA-4, PD-1 Antibodies and Bevacizumab in Resectable HCC (Prophet)
Shanghai Zhongshan Hospital0 个研究点目标入组 90 人开始时间: 2026年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Average depth of pathological response
研究概览
简要总结
The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC
详细描述
This study is a prospective, national multi-center clinical trial. Patients with initially resectable hepatocellular carcinoma were randomly assigned to receive neoadjuvant therapy in three groups: IBI310+ sintilimab + bevacizumab (Group A), IBI310+ sintilimab (Group B), and Sintilimab + bevacizumab (Group C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent shall be obtained prior to any trial-related procedures.
- •Male or female patients aged ≥18 years and ≤75 years.
- •Initial resectable hepatocellular carcinoma (HCC) confirmed by imaging, pathology or cytology.
- •No macrovascular tumor thrombus or extrahepatic metastasis detected on imaging examinations.
- •Single intrahepatic tumor >5 cm in diameter, or 2-3 intrahepatic tumors with no restriction on tumor diameter (corresponding to CNLC stage Ib-IIa of primary liver cancer in China).
- •The maximum tumor diameter < 8 cm.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or
- •Child-Pugh Class A liver function.
- •No prior systemic therapy or locoregional therapy for HCC; patients with recurrence ≥2 years after previous curative surgical resection or ablation are eligible for enrollment.
- •At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- •Adequate organ function.
排除标准
- •Histologically or cytologically confirmed tumors containing components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other mixed subtypes.
- •History of hepatic encephalopathy or prior liver transplantation.
- •Currently participating in an interventional clinical trial, or received any investigational medicinal product or investigational device within 4 weeks prior to the first study drug administration.
- •Prior receipt of any of the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other T-cell co-stimulatory or co-inhibitory receptors (including but not limited to CTLA-4, OX-40, CD137).
- •Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory agents (including thymopeptides, interferons, interleukins; excluding local intrapleural administration for controlling pleural effusion) within 2 weeks prior to the first study drug administration.
- •History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years before the first study drug administration. Replacement therapies (e.g., thyroxine, insulin, physiologic corticosteroids for adrenal or pituitary insufficiency) shall not be regarded as systemic treatment.
- •Receiving systemic corticosteroid therapy (excluding intranasal, inhaled, or other locally administered corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first study drug administration.
- •Note: Physiologic doses of corticosteroids (≤10 mg prednisone equivalent per day) are permitted.
- •Known history of allogeneic solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- •Known hypersensitivity to any study drug used in this trial.
- •Have not fully recovered from toxicities and/or complications induced by any prior intervention before study treatment initiation.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Untreated active hepatitis B virus (HBV) infection.
- •Subjects with active hepatitis C virus (HCV) infection.
- •Received any live vaccine within 30 days prior to the first study drug administration (Day 1 of Cycle 1).
- •Pregnant or lactating women.
- •Presence of any severe or uncontrolled systemic disease.
结局指标
主要结局
Average depth of pathological response
时间窗: 6 months
Pathological response depth is defined as the proportion of non-viable tumors in surgical specimens to the total sample after neoadjuvant therapy. The average pathological response depth is defined as the average value of the pathological response depth.
次要结局
- 1y-RFS rate(12 months)
- 1y-EFS rate(12 months)
研究者
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