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

Hepatocellular Carcinoma Clinical Trial

Official title:

TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04559607
• Other study ID #: MA-HCC-II-005
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: January 31, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Hepatocellular Carcinoma

Intervention

Drug:
• Camrelizumab
Camrelizumab: 200mg, iv, Q3W

Device:
• TACE
TACE if necessary

Drug:
• Apatinib
Apatinib: 250m, po, QD

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) by investigator	PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.	Up to ~2 years
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death from any cause.	Up to ~4 years
Secondary	PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)	PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)	Up to ~2 years
Secondary	Time to untreatable (unTACEable) progression (TTUP) by investigator	TTUP is defined as the time from randomization to Child-Pugh grade C, intrahepatic tumor progression (>50% increase vs baseline), MVI or EHS (diameter>10 mm), and met the JSH criteria for TACE failure/refractoriness.	Up to ~2 years