Camrelizumab and Rivoceranib Plus HAIC as Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 398
- 试验地点
- 2
- 主要终点
- dual primary endpoint: EFS and OS
研究概览
简要总结
The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.
详细描述
This is a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and HAIC as conversion therapy.
Eligible patients will be randomized into camrelizumab + rivoceranib + HAIC group and camrelizumab + rivoceranib group. Patients in camrelizumab + rivoceranib + HAIC group will receive systemic therapy and no more than 6 cycles HAIC procedure. Tumor response assessment using CT and/or MRI will be conducted according to RECIST v1.1. Those who are assessed as CR/PR or SD and considered suitable for curative hepatic resection will receive surgry. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection.The first administration of postoperative camrelizumab + rivoceranib treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative camrelizumab + rivoceranib treatment. Patients in camrelizumab + rivoceranib group will receive the systemic therapy until progression or unacceptable toxicity.
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
- •Signed Informed Consent Form (ICF)
- •Aged ≥18 years and ≤75 years at time of signing ICF
- •Documented diagnosis of HCC confirmed by histology/cytology or clinically
- •Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
- •Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry
- •At least one measurable lesion (per RECIST v1.1) untreated lesion
- •ECOG performance status of 0 or 1
- •Child-Pugh ≤7 score
- •Life expectancy ≥12 weeks
- •Adequate organ function
- •No prior anti-tumor systemic therapies for HCC
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Other active malignant tumor except HCC within 5 years or simultaneously
- •Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)
- •There is an absolute contraindication to HAIC
- •History of hepatic encephalopathy
- •Diffuse HCC, intrahepatic tumor burden > 50%
- •PVTT reaching the superior mesenteric vein, and bilateral PVTT are present
- •Clinically significant ascites
- •Prior allogeneic stem cell or solid organ transplantation
研究组 & 干预措施
camrelizumab + rivoceranib
干预措施: camerlizumab + rivoceranib (Drug)
camrelizumab + rivoceranib + HAIC
干预措施: camrelizumab combined with rivoceranib and HAIC (Drug)
结局指标
主要结局
dual primary endpoint: EFS and OS
时间窗: 36 months
Event-free survival (EFS), defined as the time from randomization to progression (RECIST v1.1), recurrence and death from any cause. Overall survival (OS) after randomization, defined as the time from randomization to death from any cause
R0 rate
时间窗: 24 months
R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin
次要结局
- MPR rate(24 months)
- ORR(24 months)
- DCR(24 months)
- pCR rate(24 months)
- AE(24 months)