Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

January 13, 2026 updated by: Jian-Hong Zhong, Guangxi Medical University

Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma: A Multicenter Retrospective Study in Guangxi, China (GUIDANCE)

This multicenter retrospective study which included patients with hepatocellular carcinoma (HCC) who received conversion or neoadjuvant therapy to explore the best treatment options and the best benefit group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

More than 50% patients with initial hepatocellular carcinoma (HCC) are diagnosed as intermediate or advanced stage diease. Transarterial chemoembolization and systemic therapy are main treatments for these patients. With the rise of targeted drugs and immunotherapy, more and more patients with advanced HCC have access to curative treatment, thereby extending their overall survival time. In clinical practice, there are many combinations used to treat these patients. However, the safety and efficacy of conversion or neoadjuvant therapy in HCC patients remains controversial.

The aim of this project is to establish a multicentre database from Guangxi province, China, to include as many HCC patients receiving conversion or neoadjuvant therapy as possible. HCC patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (HAIC), transcatheter arterial chemoembolization (TACE), tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or radiotherapy were retrospectively enrolled. The purpose of this project is to explore the best beneficiaries of conversion or neoadjuvant therapy, the best treatment strategy, and the follow-up treatment options after successful conversion therapy. The ultimate objective is to provide evidence for the necessity and feasibility of conversion or neoadjuvant therapy for patients with HCC.

The data for this study were derived from the database of the regional registry platform entitled "Guangxi Liver Cancer Clinical Study Alliance (GUIDANCE)" sponsored by the Guangxi Anticancer Association Liver Cancer Committee. All of the included patients were not previously reported and were not enrolled in those industry-sponsored clinical trials.

Study Type

Observational

Enrollment (Estimated)

2000

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
    • China
      • Nanning, China, China, 530021

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma who received conversion or neoadjuvant therapy as initial treatment would be included.

Description

Inclusion Criteria:

  • Histologically or clinically confirmed diagnosis of HCC.
  • Patients who received conversion or neoadjuvant therapy as initial treatment, including hepatic artery infusion chemotherapy (HAIC), transcatheter arterial chemoembolization (TACE), tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or radiotherapy.
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1.
  • With Child-Pugh 5~7 scores.

Exclusion Criteria:

  • Concurrent with other malignancies within 5 years.
  • Incomplete medical data.
  • Follow-up time less than 3 months.

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
Conversion or Neoadjuvant Therapy
Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.
Drug: Conversion or neoadjuvant therapy.
Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
1 year overall survival
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 1 year
1 year progression-free survival
1 year

Collaborators and Investigators

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

Sponsor

Guangxi Medical University

Investigators

  • Principal Investigator: Jian-Hong Zhong, Ph.D, Guangxi Medical University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 4, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUIDANCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study are available on request from the corresponding author, Jian-Hong Zhong, upon reasonable request.

IPD Sharing Time Frame

After papers were published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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