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 Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver Transplantation

Sponsor
Ningbo Medical Center Lihuili Hospital
Study ID
NCT07310836
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Locoregional Therapy (LRT) + Systemic Drug Therapy — COMBINATION_PRODUCT
    Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.

Study Details

This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. The primary objective is to assess the outcomes of these "intention-to-treat" patients who received locoregional therapies (LRT, such as TACE or radiotherapy) in combination with systemic therapy (anti-VEGF/Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors) as a "conversion therapy" prior to potential transplantation. This approach is distinct from traditional bridging or down-staging therapies by incorporating more aggressive systemic regimens. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients beyond UCSF criteria who received the combined conversion therapy between January 2020 and December 2024. A control group of about 200 patients who met the UCSF criteria and were directly listed for transplantation in the same period will be used for comparison. Data will be collected from medical records and the China Liver Transplant Registry (CLTR), with follow-up until December 2025. Primary outcome measures include: Objective Response Rate (ORR) of conversion therapy per mRECIST. Rate of successful down-staging to meet UCSF criteria. 1-, 2-, and 3-year overall survival (OS) rates of the intention-to-treat population. Actual liver transplantation rate after successful conversion. Post-transplant 1-, 2-, and 3-year OS and recurrence-free survival (RFS) rates. Secondary outcomes involve: Safety profiles of both conversion therapy and subsequent transplantation. Analysis of factors influencing conversion success and treatment efficacy. Determination of an optimal washout period for Immune Checkpoint Inhibitors prior to transplantation. The study seeks to provide high-level evidence for optimizing pre-transplant conversion strategies for advanced HCC patients currently outside standard transplant criteria.

Key Dates

First listed
Dec 30, 2025
Start date
Dec 20, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Beyond UCSF Criteria Cohort
    HCC patients receiving conversion therapy beyond UCSF criteria
  • Arm: Within UCSF Criteria Cohort
    HCC patients within UCSF Criteria Cohort

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From the start of conversion therapy until the completion of therapy (assessed up to 24 months). ]

Central Contacts

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