NCT04559607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

September 9, 2020

Last Update Submit

December 10, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Overall Survival (OS)

    Up to ~4 years

  • 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

    Up to ~2 years

Study Arms (2)

Experimental group: TACE+Camrelizumab+Apatinib

EXPERIMENTAL

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

Drug: CamrelizumabDevice: TACEDrug: Apatinib

Control group: TACE

ACTIVE COMPARATOR

TACE

Device: TACE

Interventions

CamrelizumabDRUG

Camrelizumab: 200mg, iv, Q3W

Experimental group: TACE+Camrelizumab+Apatinib
TACEDEVICE

TACE if necessary

Control group: TACEExperimental group: TACE+Camrelizumab+Apatinib
ApatinibDRUG

Apatinib: 250m, po, QD

Experimental group: TACE+Camrelizumab+Apatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumabapatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Gao-Jun Teng, Doctor

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 23, 2020

Study Start

September 11, 2020

Primary Completion

August 31, 2024

Study Completion

January 31, 2026

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)