TACE Combined With Donafenib and Tislelizumab in Unresectable Hepatocellular Carcinoma

January 30, 2024 updated by: Jian-Hong Zhong, Guangxi Medical University

Transarterial Chemoembolization Combined With Donafenib and Tislelizumab in Unresectable Hepatocellular Carcinoma

Most hepatocellular carcinoma (HCC) are found in the intermediate or advanced stage. The patients lose the opportunity of curative surgical resection. In clinical practice, unresectable HCC is often encountered with large tumor lesions and insufficient remaining liver volume. It is expected that the benefit of direct surgical resection will not exceed that of non-surgical treatment if the tumor is limited in scope but with unclear boundaries, surrounding small foci, or adjacent to important vascular structures, or combined with secondary or higher portal vein tumor thrombus. These patients account for a significant proportion of unresectable HCC, but have the potential for surgical resection. If the investigators can make full use of the existing HCC treatment, the patients hope to obtain radical surgical resection opportunities and better long-term survival after tumor shrinkage and tumor necrosis boundary becomes clear.

Transcatheter arterial chemoembolization (TACE) has been the standard arterial treatment for advanced HCC. Donafenib is a multikinase inhibitor that is the first-line treatment for hepatocellular carcinoma. Tislelizumab is an immune checkpoint inhibitor and a first-line treatment for HCC. This study investigated the efficacy and safety of TACE combined with donafenib and tislelizumab in the treatment of unresectable HCC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Jian-Hong Zhong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Had Child-Pugh score 5-7 liver function, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function at the time of treatment initiation;
  • With stage Ⅰb, Ⅱa, Ⅱb or Ⅲa hepatocellular carcinoma (HCC) based on the Chinese liver Cancer Staging System (CNLC);
  • With unresectable HCC because of insufficient residual liver volume;
  • Expected survival time ≥6 months;
  • Hematology indexes should meet the following conditions: hemoglobin ≥90 g/L; platelet ≥80; total bilirubin ≤1.5×ULN; alanine transaminase ≤3×ULN; aspertate aminotransferase ≤ 3 x ULN; alkaline phosphatase ≤2.5×ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5×ULN;
  • Urinary protein <2+ or 24 h urinary protein quantity < 1.0g;
  • For women of reproductive age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) are required during the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days prior to inclusion in the study; For male patients whose partners have reproductive potential, effective contraception should be used during the study period and for 120 days after the end of the study.

Exclusion Criteria:

  • Combined with other malignant tumors;
  • Previously received local treatment of HCC such as Hepatic Artery Infusion Chemotherapy, transarterial (chemo)embolization, or local ablation;
  • Those who have received or are using one of the following three types of drugs in the past 6 months: Immune checkpoint inhibitors, including but not limited to Atezolizumab, Nivolumab, pembrolizumab, Camrelizumab, Tislelizumab, triplizumab, sintilimab, etc.; Molecular targeted therapy, including but not limited to sorafenib, lenvatinib, donafenib, apatinib, regorafenib, anrotinib, bevacizumab, etc.; systemic chemotherapy drugs (such as doxorubicin, oxaliplatin, 5-FU, S-1, etc.);
  • The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);
  • Active infection, or body temperature ≥ 38.5℃ 7 days before enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transarterial chemoembolization combined with Donafenib and Tislelizumab
Patients with unresectable hepatocellular carcinoma were received transarterial chemoembolization combined with Donafenib and Tislelizumab
Drug: Transarterial chemoembolization combined with Donafenib and Tislelizumab
Patients with unresectable hepatocellular carcinoma were received transarterial chemoembolization combined with Donafenib and Tislelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: One year
The proportion of progression-free survival in one year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: One year
The proportion of overall survival in one year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Principal Investigator: Shao-Ping Liu, M.D, The Eighth Affiliated hospital of the Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

January 20, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRONT-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Original data can be obtained from the corresponding authors in accordance with privacy/ethical restrictions.

IPD Sharing Time Frame

After the full paper was published.

IPD Sharing Access Criteria

use the data for further analysis, for example, meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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