Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Conversion or neoadjuvant therapy.

• Registration Number: NCT06405321
• Lead Sponsor: Guangxi Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Study First Posted: 2024-05-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conversion or Neoadjuvant Therapy	Conversion or neoadjuvant therapy.	Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year	1 year overall survival

Secondary Outcome Measures

Name	Time	Method
progression-free survival	1 year	1 year progression-free survival

Trial Locations

Locations (1)

Jian-Hong Zhong; 🇨🇳 Nanning, China