Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT05862337
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anlotinib hydrochloride capsules + Penpulimab injection Anlotinib hydrochloride capsules, Penpulimab injection Anlotinib hydrochloride capsules + Penpulimab injection, 21 days as a treatment cycle. Anlotinib hydrochloride capsules -matching placebo+ Penpulimab injection -matching placebo Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo Anlotinib hydrochloride capsules -matching placebo+ penpulimab injection -matching placebo, 21 days as a treatment cycle.
- Primary Outcome Measures
Name Time Method Recurrence-free survival (RFS) 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.
- Secondary Outcome Measures
Name Time Method Time to recurrence(TTR) Baseline up to 3 years. TTR 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, whichever occurred first.
Time to extrahepatic metastasis or macrovascular invasion Baseline up to 3 years. Time to extrahepatic metastasis or macrovascular invasion as assessed by the investigator.
Overall survival (OS) Baseline up to 3 years. OS defined as the time from the date of randomization until the date of death due to any cause.
Objective response rate (ORR) after first recurrence Baseline up to 3 years. subjects with evaluable tumor lesion status who were cross-treated with Anlotinib hydrochloride capsules combined with Penpulimab injection developed complete response or partial response after a first HCC relapse as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Trial Locations
- Locations (67)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing YouAn Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, China
Scroll for more (57 remaining)The First Affiliated Hospital of Bengbu Medical College🇨🇳Bengbu, Anhui, ChinaLu Zheng, DoctorContact+86 13721179461luzhengdr@163.com