Status:
UNKNOWN
TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC
Lead Sponsor:
Zhongda Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 pat...
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 immu...
Eligibility Criteria
Inclusion
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment;
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
- Has repeated measurable intrahepatic lesions;
Exclusion
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
Key Trial Info
Start Date :
December 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT05332821
Start Date
December 28 2022
End Date
August 31 2023
Last Update
December 29 2022
Active Locations (2)
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1
Gao-Jun Teng
Nanjing, China
2
Zheng-Gang Ren
Shanghai, China