Clinical Research Directory
Browse clinical research sites, groups, and studies.
Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma
Sponsor: The First Affiliated Hospital with Nanjing Medical University
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.
Official title: Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2023-01-31
Completion Date
2027-11-01
Last Updated
2024-12-31
Healthy Volunteers
No
Interventions
Camrelizumab
Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib Mesylate
Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
Radical surgery
Radical surgery
Preoperative TACE treatment
TACE treatment before preoperative camrelizumab combined with apatinib mesylate
Camrelizumab
Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery
Apatinib Mesylate
Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery
Locations (1)
Jiangsu Province Hospital
Nanjing, Jiangsu, China