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NCT07368023

A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma

Sponsor: Ningbo Medical Center Lihuili Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-01-25

Completion Date

2026-05-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Locoregional Therapy (LRT) + Systemic Drug Therapy

Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.

Locations (1)

Ningbo Medical Centre Lihuili Hospital

Ningbo, Zhejiang, China