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

NCT ID: NCT04559607

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group: TACE+Camrelizumab+Apatinib

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

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

Camrelizumab: 200mg, iv, Q3W

TACE

Intervention Type DEVICE

TACE if necessary

Apatinib

Intervention Type DRUG

Apatinib: 250m, po, QD

Control group: TACE

TACE

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type DEVICE

TACE if necessary

Interventions

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Camrelizumab

Camrelizumab: 200mg, iv, Q3W

Intervention Type DRUG

TACE

TACE if necessary

Intervention Type DEVICE

Apatinib

Apatinib: 250m, po, QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao-jun Teng

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao-Jun Teng, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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MA-HCC-II-005

Identifier Type: -

Identifier Source: org_study_id