A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study of Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection in Patients With High Risk of Relapse After Radical Surgery or Ablation of Hepatocellular Carcinoma (HCC).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 67
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1; Predicted survival ≥12 weeks.
- •Subjects with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or who meet the diagnostic criteria for Primary Liver Cancer 2022 or the American Association for the Study of Hepatology (AASLD) hepatocellular carcinoma.
- •Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to randomization (multiple modalities or combined or multiple treatments are not acceptable).
- •No major vena portae 3 (Vp3) or vena portae 4 (Vp4) in the portal vein or any level of vascular invasion in the hepatic vein or inferior vena cava.
- •No extrahepatic metastasis.
- •High risk factors for recurrence after radical resection or complete ablation.
- •Complete recovery from surgical resection or ablation within 4 weeks before randomization.
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology.
- •Evidence of residual, recurrent, or metastatic disease at randomization.
- •More than one surgical treatment for hepatocellular carcinoma; Received more than 1 prophylactic Transcatheter Arterial Chemoembolization (TACE) treatment after surgery; or received Hepatic Artery Infusion Chemotherapy (HAIC) therapy after surgery.
- •Previous use of antiangiogenic drugs or PD-1, Programmed Cell Death-Ligand 1 (PD-L1) and other related immunotherapy drugs or systemic chemotherapy drugs.
研究组 & 干预措施
Anlotinib hydrochloride capsules + Penpulimab injection
Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle.
干预措施: Anlotinib hydrochloride capsules, Penpulimab injection (Drug)
Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo
Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
干预措施: Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo (Drug)
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: Baseline up to 3 years.
RFS assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, or death from any cause, whichever occurred first.
次要结局
- Time to recurrence(TTR)(Baseline up to 3 years.)
- Time to extrahepatic metastasis or macrovascular invasion(Baseline up to 3 years.)
- Overall survival (OS)(Baseline up to 3 years.)
- Objective response rate (ORR) after first recurrence(Baseline up to 3 years.)