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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Non-resectable Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo Medical Centre Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Locoregional Therapy (LRT) + Systemic Drug Therapy

Combination Product

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

Primary outcomes

Conversion Rate

Time frame: 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

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caide Lu, Professor

CONTACT

[email protected]

+8613957800900

Shuqi Mao, Professor

CONTACT

[email protected]

+8617855848257

Sponsors and collaborators

Lead sponsor

Ningbo Medical Center Lihuili Hospital

Other Gov

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 26, 2026
Registry last updated: Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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