TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC (CHANCE2201)

Southeast University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE; Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

Study type: Observational

Funder types: Other

Identifiers

NCT05332821

CHANCE2201

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) and molecular target therapies in patients with advanced-stage 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 transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies(including, VEGF-TKI/ bevacizumab) in patients with advanced-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.

Enrollment: 474 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
3. Has not received any previous 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;

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;

Trial design

474 participants in 2 patient groups

Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

Description:

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；

Treatment:

Procedure: TACE

Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

Control group: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

Description:

The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；

Treatment:

Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab