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

Sponsor
Zhongda Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04559607
Collaborator
(none)
188
1
2
35.6
5.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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 are that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
188 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials
Actual Study Start Date :
Sep 11, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) by investigator [Up to ~2 years]

    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 that included intrahepatic tumor progression (50% increased vs baseline) according to Response Evaluation Criteria in Cancer of the Liver (RECICL) version 5, transient deterioration of liver function to Child-Pugh C right after TACE, macrovascular invasion (MVI) or extra hepatic spread (EHS) (diameter>10 mm). Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.

Secondary Outcome Measures

  1. Overall Survival (OS) [Up to ~4 years]

    OS is defined as the time from randomization to death from any cause.

  2. PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) [Up to ~2 years]

    PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)

  3. PFS by independent review committee according to mRECSIT [Up to ~2 years]

    PFS by independent review committee according to mRECSIT

  4. Time to untreatable (unTACEable) progression (TTUP) by investigator [Up to ~2 years]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Has a diagnosis of HCC confirmed by radiology, histology, or cytology

-≥18 years

  • China liver cancer staging: IIb-IIIa

  • Child-Pugh score ≤6 point

  • No prior systemic anticancer therapy for HCC

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongda Hospital Nanjing Jiangsu China

Sponsors and Collaborators

  • Zhongda Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gao-jun Teng, Chief physician, Zhongda Hospital
ClinicalTrials.gov Identifier:
NCT04559607
Other Study ID Numbers:
  • MA-HCC-II-005
First Posted:
Sep 23, 2020
Last Update Posted:
Nov 30, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2020