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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: TACE/HAIC; Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Lan Zhang, MD, Ph.D; Phone Number: 13918876432; Email: zhang.lan@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group LS; Logical therapy combined with systemic therapy	Procedure: TACE/HAIC; TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment; Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents; Agents were administrated based on the instructions recommended
Group S; Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents）	Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents; Agents were administrated based on the instructions recommended

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	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)	Up to 48 months
ORR	The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1	Up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS was defined as the interval from the date of the initial administration of any drug/procedure to death from any cause.	Up to 48 months
Safety	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.	Up to 48 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Angiogenesis Inhibitors
• Other Study ID Numbers: ZL-2024-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No