Clinical trial

A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven

Name
ZL-2024-06
Description
This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.
Trial arms
Trial start
2024-05-01
Estimated PCD
2024-08-01
Trial end
2024-10-01
Status
Not yet recruiting
Treatment
TACE/HAIC
TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
Arms:
Group LS
PD-1/PD-L1 inhibits and anti-angiogenic agents
Agents were administrated based on the instructions recommended
Arms:
Group LS, Group S
Size
150
Primary endpoint
PFS
Up to 48 months
ORR
Up to 48 months
Eligibility criteria
Inclusion Criteria: * Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically. * Patients with Barcelona (BCLC) stage B and C beyond up to seven; * Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy); * Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications); \*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week * TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment; * TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE; * There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria Exclusion Criteria: * Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed; * Patients who do not meet the above definition of combination therapy; * Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-05-21

1 organization

1 product

1 indication