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

Last updated: December 28, 2022
Sponsor: Zhongda Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Cancer/tumors

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05332821
CHANCE2201
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 spreadand/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 includemarketed drugs but are not limited to HCC approval;
  5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatmentor before treatment;
  6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combinationtherapy after TACE treatment;
  7. Has repeated measurable intrahepatic lesions;

Exclusion

Exclusion Criteria:

  1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixedhepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) arenot eligible;
  2. Unable to meet criteria of combination timeframe described above;

Study Design

Total Participants: 474
Study Start date:
December 28, 2022
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Gao-Jun Teng

    Nanjing,
    China

    Active - Recruiting

  • Zheng-Gang Ren

    Shanghai,
    China

    Active - Recruiting

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