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

Not yet recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TACE/HAIC; Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents

• Registration Number: NCT06423144
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group LS	TACE/HAIC	Logical therapy combined with systemic therapy
Group LS	PD-1/PD-L1 inhibits and anti-angiogenic agents	Logical therapy combined with systemic therapy
Group S	PD-1/PD-L1 inhibits and anti-angiogenic agents	Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents）

Primary Outcome Measures

Name	Time	Method
PFS	Up to 48 months	The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1)
ORR	Up to 48 months	The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
OS	Up to 48 months	OS was defined as the interval from the date of the initial administration of any drug/procedure to death from any cause.
Safety	Up to 48 months	Safety was defined the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). The severity of AEs were evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE) v5.0.