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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Conversion Rate — From the start of conversion therapy until the completion of therapy (assessed up to 24 months).
  Proportion of ITT patients with initially unresectable HCC successfully down-staged to resectability after conversion therapy (per MDT reassessment).
• 1-, 2-, and 3-year OS in ITT Population — Starting from conversion therapy, evaluate at 1, 2, and 3 years.
  Proportion of patients in the ITT population alive at 1, 2, and 3 years after initiation of conversion therapy (Kaplan-Meier method).
• Resection Rate After Conversion — From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).
  Proportion of patients who successfully undergo curative resection after down-staging.

Trial sites (1)

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