Status:
UNKNOWN
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers
Lead Sponsor:
Zhongda Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to id transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carc...
Eligibility Criteria
Inclusion
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- 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 up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
- 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 according to RECIST v1.1;
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;
- Missing follow-up data;
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05278195
Start Date
April 1 2022
End Date
December 1 2023
Last Update
March 14 2022
Active Locations (1)
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1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009