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

January 20, 2026 updated by: Caide Lu, Ningbo Medical Center Lihuili Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • Ningbo Medical Centre Lihuili Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective single-center cohort study includes 300 HCC patients (2018-2024), divided by initial resectability:

Initially Unresectable HCC Cohort（N=100）: Received multimodal conversion therapy (LRT + anti-VEGF/TKIs + ICIs) aiming to downstage tumors for resection.

Initially Resectable HCC Cohort（N=200）: Underwent direct radical resection without prior conversion therapy.

Patients were aged ≥16 with CNLC stage I-IIIA HCC. Exclusions: extrahepatic metastasis or Cheng's type IV PVTT/type II-III IVCTT. Data are collected retrospectively from EMR and an HCC database.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initially Unresectable HCC with Conversion Therapy
This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as unresectable (due to surgical inoperability or oncological unresectability per multidisciplinary team evaluation) but intended for curative treatment. All patients in this cohort received multimodal conversion therapy between January 2018 and December 2024. The therapy aimed to downstage the tumor and primarily included a combination of locoregional therapies (LRT) (such as TACE, HAIC, or radiotherapy) and systemic drug therapy (including anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors). Patient data are collected retrospectively from electronic medical records and the HCC clinical database.
Combination product: Locoregional Therapy (LRT) + Systemic Drug Therapy
Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.
Initially Resectable HCC
This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as resectable and suitable for curative surgery per multidisciplinary team evaluation. All patients in this cohort underwent direct radical resection (curative-intent surgery) as the primary treatment between January 2018 and December 2024, without receiving prior locoregional or systemic conversion therapy. Patient data are collected retrospectively from electronic medical records and the HCC clinical database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
Proportion of patients in the ITT population alive at 1, 2, and 3 years after initiation of conversion therapy (Kaplan-Meier method).
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).
Proportion of patients who successfully undergo curative resection after down-staging.
From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo Medical Center Lihuili Hospital

Investigators

  • Principal Investigator: Caide Lu, Professor, Ningbo Medical Centre Lihuili Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025PJ484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision regarding the sharing of individual participant data (IPD) has not yet been made. The research team is currently assessing the feasibility, institutional policies, and ethical considerations related to data de-identification and sharing. A final plan will be determined prior to the completion of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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