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

Fudan University

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents; Procedure: TACE/HAIC

Study type: Observational

Funder types: Other

Identifiers

NCT06423144

ZL-2024-06

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 2 patient groups

Group LS

Description:

Logical therapy combined with systemic therapy

Treatment:

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

Procedure: TACE/HAIC

Group S

Description:

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

Treatment:

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