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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Camrelizumab; Device: TACE; Drug: Apatinib

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hai-Dong Zhu, Doctor; Phone Number: 13851420979; Email: zhuhaidong9509@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: TACE+Camrelizumab+Apatinib; Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE	Drug: Camrelizumab; Camrelizumab: 200mg, iv, Q3W; Device: TACE; TACE if necessary; Drug: Apatinib; Apatinib: 250m, po, QD
Active Comparator: Control group: TACE; TACE	Device: TACE; TACE if necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death from any cause.	Up to ~4 years
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
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

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-Jun Teng, Doctor, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: MA-HCC-II-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No