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

Southeast University

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Camrelizumab; Device: TACE; Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04559607

MA-HCC-II-005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

• Participants who had another previous or current malignant tumor, except for early-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 marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
• Participants who had congenital or acquired immune deficiency, such as HIV infection
• Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
• Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Experimental group: TACE+Camrelizumab+Apatinib

Experimental group

Description:

Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE

Treatment:

Device: TACE

Drug: Camrelizumab

Drug: Apatinib

Control group: TACE

Active Comparator group

Description:

TACE

Treatment:

Device: TACE