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RECRUITING
NCT05613478
PHASE3

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

DRUG

Camrelizumab

Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery

DRUG

Apatinib Mesylate

Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery

PROCEDURE

Radical surgery

Radical surgery

PROCEDURE

Preoperative TACE treatment

TACE treatment before preoperative camrelizumab combined with apatinib mesylate

DRUG

Camrelizumab

Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery

DRUG

Apatinib Mesylate

Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery

Locations (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China