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

NCT05613478 | Recruiting Phase 3

• 1 other identifier: 2022-SR-558
• Study Type: interventional
• Target: 130
• 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 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.

Conditions

Hepatocellular Carcinoma; Immunotherapy; Preoperative

Outcome Measures

Primary Outcomes (1)

• 2 year event-free survival（2y-EFS）

  2y-EFS 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.

  2-year

Secondary Outcomes (7)

• R0 resection rate

  30-day

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

  30-day

• the rate of subjects with pathological complete response (pCR)

  30-day

• Overall survival (OS)

  3-year

• Event-free survival (EFS)

  3-year

Study Arms (2)

Experimental group

EXPERIMENTAL

Preoperative TACE treatment → preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles)

Drug: Camrelizumab; Drug: Apatinib Mesylate; Procedure: Radical surgery; Procedure: Preoperative TACE treatment

Control group

ACTIVE COMPARATOR

Radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles)

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

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

Preoperative TACE treatment PROCEDURE

TACE treatment before preoperative camrelizumab combined with apatinib mesylate

Experimental group

Eligibility Criteria

• Age: 18 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 years old, no gender limit.
• Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
• CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation.
• 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

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

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

• Xuehao Wang, professor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• Yongxiang Xia

  The First Affiliated Hospital with Nanjing Medical Univer

  STUDY DIRECTOR

Central Study Contacts

Xuehao Wang, professor

CONTACT

86-025-68303211; Wangxh@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 14, 2022
• Study Start: January 31, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)