Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study (CHANCE001)

Southeast University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE; Other: TACE+ICIs

Study type: Observational

Funder types: Other

Identifiers

NCT04975932

TACE-ICIs-RWS

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .

Full 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 TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.

Enrollment: 826 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed with HCC by radiology, histology, or cytology;
2. patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
3. during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
4. patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.

Exclusion criteria

1. exceeding the time interval of the combination therapy defined above;
2. missing follow-up data;

Trial design

826 participants in 2 patient groups

Study group: TACE+ICIs

Description:

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); ICIs: atezolizumab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab or other ICIs

Treatment:

Other: TACE+ICIs

Control group: TACE

Description:

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);

Treatment:

Procedure: TACE