PD-1/PD-L1 Inhibitors and Anti-angiogenic Therapy Combined With/Without TACE/HAIC in Patients With BCLC B/C Hepatocellular Carcinoma Beyond Up-to-7

NCT ID: NCT06423144

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-10-31

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group LS

Logical therapy combined with systemic therapy

TACE/HAIC

Intervention Type: PROCEDURE

TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;

PD-1/PD-L1 inhibits and anti-angiogenic agents

Intervention Type: DRUG

Agents were administrated based on the instructions recommended

Group S

Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents）

PD-1/PD-L1 inhibits and anti-angiogenic agents

Intervention Type: DRUG

Agents were administrated based on the instructions recommended

Interventions

TACE/HAIC

TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;

Intervention Type: PROCEDURE

PD-1/PD-L1 inhibits and anti-angiogenic agents

Agents were administrated based on the instructions recommended

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lan Zhang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lan Zhang, MD, Ph.D

Role: CONTACT

zhang.lan@zs-hospital.sh.cn

13918876432

Other Identifiers

ZL-2024-06

Identifier Type: -

Identifier Source: org_study_id