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

NCT04521153 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ZS-ZJ-SK-2020
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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 for phase 2 study and event-free survival (EFS) by investigator for phase 3 study of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate EFS by Blinded Independent Review Committee, the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, 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.

Conditions

Hepatocellular Carcinoma; Immunotherapy; Molecular Targeted Therapy

Keywords

Camrelizumab; apatinib mesylate; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• Event-free survival (EFS) assessed by investigator

  The primary endpoint of phase 3 study is EFS assessed by investigator, which is defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.

  up to 3 years

• The rate of subjects of major pathological response (MPR)

  The primary endpoint of phase 2 study is the rate of subjects of MPR in the first 60 patients in the experimental group. MPR is defined as less than or equal to 50% residual tumor after neoadjuvant therapy of camrelizumab and apatinib therapy.

  From enrollment to 30 days post-surgery

Secondary Outcomes (7)

• Overall survival (OS)

  up to 5 years

• EFS assessed by Blinded Independent Review Committee (BIRC)

  up to 3 years

• Disease-free survival (DFS) assessed by investigator

  up to 3 years

• R0 resection rate

  From enrollment to 30 days post-surgery

• The rate of subjects of major pathological response (MPR)

  From enrollment to 30 days post-surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery →sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles). One cycle of postoperative TACE treatment 4-6 weeks after surgery is allowed. (Note: Surgery within 2-4 weeks after the last administration of neoadjuvant therapy, postoperative TACE treatment at least 4 weeks after surgery, and camrelizumab combined with apatinib mesylate 4 weeks after surgery or 2-4 weeks after post-operative TACE)

Drug: Camrelizumab; Drug: Apatinib Mesylate; Procedure: Radical surgery

Control group

ACTIVE COMPARATOR

Radical surgery, one cycle of postoperative TACE treatment 4-6 weeks after surgery is allowed. (Note: Postoperative TACE treatment at least 4 weeks after surgery)

Procedure: Radical surgery

Interventions

Camrelizumab DRUG

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

Experimental group

Apatinib Mesylate DRUG

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

Experimental group

Radical surgery PROCEDURE

Radical surgery

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this study and sign an informed consent form
• Age 18\~75 years old, no gender limit
• Hepatocellular carcinoma confirmed by histopathology, cytology or imaging
• CNLC stage Ib/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus
• Child-Pugh score: A grade (≤6 points)
• ECOG PS score: 0-1 points

You may not qualify if:

• 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.
• Currently accompanied by interstitial pneumonia or interstitial lung disease
• Existence of active autoimmune disease or history of autoimmune disease and may relapse
• Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count \>15\*10\^9/L
• Patients with congenital or acquired immune deficiencies (such as HIV-infected persons)
• Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jian Zhou, Doctor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: March 25, 2021
• Primary Completion: July 31, 2025
• Study Completion: March 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)