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NCT Number: NCT06405321

Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Conversion or neoadjuvant therapy.

Drug

Patients with hepatocellular carcinoma received conversion or neoadjuvant therapy.

Primary outcomes

  1. Overall survival

    Time frame: 1 year

    1 year overall survival

Secondary outcomes

  1. progression-free survival

    Time frame: 1 year

    1 year progression-free survival

Study contacts

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

Jian-Hong Zhong, Ph.D

CONTACT

[email protected]

+86 771 5301253 ext. +86

Liang Ma, MD

CONTACT

[email protected]

+86 771 5301253 ext. +86

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 8, 2024
Registry last updated
Jan 14, 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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