Clinical Trial

Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma

Recruiting Phase 3
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Record status
This record was last updated December 31, 2024 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival(2y-EFS) of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-11-06; most recent amendment 2024-12-30.
Trial Details
NCT Number NCT05613478
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Conditions Hepatocellular Carcinoma, Immunotherapy, Preoperative
Enrollment 130 participants
Start Date 2023-01-31
Primary Completion 2025-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-31