TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate HCC (CHANCE2202)

April 15, 2026 updated by: Gao-jun Teng, Zhongda Hospital

Efficacy and Safety of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Intermediate Stage HCC

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with PD-1/PD-L1 Inhibitors and molecular target therapies in patients with Intermediate-stage hepatocellular carcinoma (HCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with PD-1/PD-L1 Inhibitors and molecular target therapies(including, VEGF-TKI/ bevacizumab) in patients with Intermediate-stage HCC. This real-world study also would like to explore the optimal combined treatment and subgroup of HCC patients for providing further information for clinical practice and trials.

Study Type

Observational

Enrollment (Actual)

941

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
      • Nanjing, China
        • Gao-Jun Teng
      • Nanjing, China
        • Zheng-Gang Ren

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with intermediate HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions.

Description

Inclusion Criteria:

  1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
  2. Barcelona Clinic Liver Cancer (BCLC) stage B, without the presence of extrahepatic spread and/or macrovascular invasion;
  3. Has not received any previous TACE/HAIC and systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
  4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
  5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment;
  6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
  7. Has repeated measurable intrahepatic lesions according to mRECIST;

Exclusion Criteria:

  1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  2. Unable to meet criteria of combination timeframe described above;

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

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment. The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab
PD-1/PD-L1 inhibitors: atezolizumab, sintilimab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, toripalimab, durvalumab, penpulimab, and other ICIs; VEGF-TKI/bevacizumab: sorafenib, lenvatinib, donafenib, apatinib, anlotinib, bevacizumab/ bevacizumab biosimilar, and other anti-angiogenesis drugs; Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs only include marketed drugs but are not limited to HCC approval.
Procedure: TACE
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);
Control group: TACE
TACE monotherapy
Procedure: TACE
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
up to approximately 2 years
Progression free survival(PFS) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time Frame: up to approximately 2 years
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
Time Frame: up to approximately 2 years
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
up to approximately 2 years
PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame: up to approximately 2 years
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
up to approximately 2 years
Objective response rate(ORR) per mRECIST
Time Frame: up to approximately 2 years
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per mRECIST.
up to approximately 2 years
Duration of Response (DOR) per mRECIST
Time Frame: up to approximately 2 years
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
up to approximately 2 years
Disease Control Rate (DCR) per mRECIST
Time Frame: up to approximately 2 years
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
up to approximately 2 years
ORR per RESCIST 1.1
Time Frame: up to approximately 2 years
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
up to approximately 2 years
DOR per RESCIST 1.1
Time Frame: up to approximately 2 years
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.
up to approximately 2 years
DCR per RESCIST 1.1
Time Frame: up to approximately 2 years
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
up to approximately 2 years

Collaborators and Investigators

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

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Gao-Jun Teng, M.D., Zhongda hospital, Southeast university, Nanjing, China
  • Principal Investigator: Zheng-Gang Ren, M.D., Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China

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)

December 28, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

September 14, 2025

Study Registration Dates

First Submitted

April 2, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANCE2202

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

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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