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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Locoregional Therapy (LRT) + Systemic Drug Therapy.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Combination product Locoregional Therapy (LRT) + Systemic Drug Therapy
Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.
Primary outcome measures
- Conversion Rate [Time frame: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).]
- 1-, 2-, and 3-year OS in ITT Population [Time frame: Starting from conversion therapy, evaluate at 1, 2, and 3 years.]
- Resection Rate After Conversion [Time frame: From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).]
Eligibility criteria
Inclusion criteria
- Aged 16 years or older.
- Clinical and/or pathological diagnosis of hepatocellular carcinoma (HCC). China Liver Cancer (CNLC) stage I, II, or IIIA.
- Assessed by a multidisciplinary team (MDT) as having initially unresectable HCC.
Exclusion criteria
- Presence of extrahepatic metastasis.
- Presence of Cheng's type IV portal vein tumor thrombus (PVTT).
- Presence of Cheng's type II or III inferior vena cava tumor thrombus (IVCTT).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Ningbo Medical Centre Lihuili Hospital — Ningbo
Identifiers
NCT: NCT07368023 · KY2025PJ484