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

Last updated: December 30, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer/tumors

Vaccines

Liver Disease

Treatment

Radical surgery

Camrelizumab

Preoperative TACE treatment

Clinical Study ID

NCT05613478
2022-SR-558
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 hepatocellularcarcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portalvein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated withsurgical excision combined with intraoperative ablation.

  • Child-Pugh score: A grade (≤6 points).

  • ECOG PS score: 0-1 points.

Exclusion

Exclusion Criteria:

  • Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma andfibrolamellar cell carcinoma; have other active malignancies other than HCC within 5years 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 mayrelapse.

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

  • Patients with congenital or acquired immune deficiencies (such as HIV-infectedpersons).

  • Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesistargeted drugs or excipients.

Study Design

Total Participants: 130
Treatment Group(s): 4
Primary Treatment: Radical surgery
Phase: 3
Study Start date:
January 31, 2023
Estimated Completion Date:
November 01, 2027

Study Description

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. This trial includes subjects with CNLC Ib/IIa/IIb/IIIa HCC. All eligible subjects will be randomized (1:1) to experimental group or control group. In the experimental group, patients will be treated with following: neoadjuvant therapy ( perioperative TACE treatment，camrelizumab and apatinib, 2 cycles), radical surgery, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery,adjuvant therapy (camrelizumab and apatinib, 6 cycles). 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.

Connect with a study center

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

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