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Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

G

Guangxi Medical University

Status

Enrolling

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Conversion or neoadjuvant therapy.

Study type

Observational

Funder types

Other

Identifiers

NCT06405321
GUIDANCE

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Jian-Hong Zhong, Ph.D; Liang Ma, MD

Data sourced from clinicaltrials.gov

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