Status:
UNKNOWN
TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Intermediate 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 PD-1/PD-L1 Inhibitors and molecular target therapies in patients with Int...
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 B, without the presence of extrahepatic spread and/or macrovascular invasion;
- Has not received any previous TACE/HAIC and 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 according to mRECIST;
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 :
September 30 2023
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05332496
Start Date
December 28 2022
End Date
September 30 2023
Last Update
December 29 2022
Active Locations (2)
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1
Gao-Jun Teng
Nanjing, China
2
Zheng-Gang Ren
Nanjing, China