TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma

Last updated: December 10, 2023
Sponsor: Zhongda Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Liver Disorders

Liver Cancer

Abdominal Cancer

Treatment

Camrelizumab

Apatinib

TACE

Clinical Study ID

NCT04559607
MA-HCC-II-005
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology -≥18 years
  • China liver cancer staging: Ib-IIIa
  • Child-Pugh score ≤6 point
  • Previous TACE treatment(≤2 times) is permitted
  • Adequate organ and marrow function

Exclusion

Exclusion Criteria:

  • Participants who had another previous or current malignant tumor, except forearly-stage cancer with low risk of recurrence or a malignant tumor curatively treated >5 years prior to enrolment with no recurrence
  • Participants who have severe allergy to iodine, and unable to receive TACE
  • Participants who have undergone a liver transplant or allogeneic bone marrowtransplantation, or those who are in the waiting list for liver or bone marrowtransplantation
  • Participants who had congenital or acquired immune deficiency, such as HIV infection
  • Participants who had a history of gastrointestinal bleeding within 6 months prior torandomization or a definite tendency of gastrointestinal bleeding
  • Participants who had undergone arterial thromboembolism within 6 months prior torandomization or a definite tendency of gastrointestinal bleeding, such ascerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism

Study Design

Total Participants: 188
Treatment Group(s): 3
Primary Treatment: Camrelizumab
Phase:
Study Start date:
September 11, 2020
Estimated Completion Date:
January 31, 2026

Study Description

This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).

Connect with a study center

  • Zhongda Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

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