Clinical trial NCT06405321: Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma
Official title: Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma: a Multicenter Retrospective Study in Guangxi, China (GUIDANCE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: conversion therapy
neoadjuvant therapy
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma who received conversion or neoadjuvant therapy as initial treatment would be included.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: progression-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanning
country: China
facility: Jian-Hong Zhong
Study officials:
affiliation: Guangxi Medical University Cancer Hospital
name: Jian-Hong Zhong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang DL, Ye L, Zeng FJ, Liu J, Yao HB, Nong JL, Liu SP, Peng N, Li WF, Wu PS, Qin C, Su Z, Ou JJ, Dong XF, Yan YH, Zhong TM, Mao XS, Wu MS, Chen YZ, Wang GD, Li MJ, Wang XY, Yang FQ, Liang YR, Chen SC, Yang YY, Chen K, Li FX, Lai YC, Pang QQ, Liang XM, You XM, Xiang BD, Yu YQ, Ma L, Zhong JH; GUIDANCE investigators. Multicenter, retrospective GUIDANCE001 study comparing transarterial chemoembolization with or without tyrosine kinase and immune checkpoint inhibitors as conversion therapy to treat unresectable hepatocellular carcinoma: Survival benefit in intermediate or advanced, but not early, stages. Hepatology. 2025 Jan 15. doi: 10.1097/HEP.0000000000001229. Online ahead of print.
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