Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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 the rate of subjects with major pathological response and 3-year event-free survival (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 pathological complete response, EFS, overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Volunteer to participate in this study and sign an informed consent form

2. Age 18~75 years old, no gender limit

3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging

4. CNLC stage Ib/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus

5. Child-Pugh score: A-B grade (≤7 points)

6. ECOG PS score: 0-1 points

Exclusion Criteria:

1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.

2. Currently accompanied by interstitial pneumonia or interstitial lung disease

3. Existence of active autoimmune disease or history of autoimmune disease and may relapse

4. Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count >15*10^9/L

5. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons)

6. Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients