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
NCT07368023 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2026-01-26
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.
Conditions
- Hepatocellular Carcinoma
- Hepatocellular Carcinoma Non-resectable
Interventions
- COMBINATION_PRODUCT
-
Locoregional Therapy (LRT) + Systemic Drug Therapy
Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.
Sponsors & Collaborators
-
Ningbo Medical Center Lihuili Hospital
lead OTHER_GOV
Principal Investigators
-
Caide Lu, Professor · Ningbo Medical Centre Lihuili Hospital
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-25
- Primary Completion
- 2026-01-31
- Completion
- 2026-05-31
Countries
- China
Study Locations
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