Conversion or Neoadjuvant Therapy in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405321
• Other study ID #: GUIDANCE
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Guangxi Medical University
• Contact: Jian-Hong Zhong, Ph.D
• Phone: +86 771 5301253
• Email: zhongjianhong66[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Jian-Hong Zhong	Nanning

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Lai Z, He M, Bu X, Xu Y, Huang Y, Wen D, Li Q, Xu L, Zhang Y, Wei W, Chen M, Kan A, Shi M. Lenvatinib, toripalimab plus hepatic arterial infusion chemotherapy in patients with high-risk advanced hepatocellular carcinoma: A biomolecular exploratory, phase II trial. Eur J Cancer. 2022 Oct;174:68-77. doi: 10.1016/j.ejca.2022.07.005. Epub 2022 Aug 15. — View Citation

Zhang TQ, Geng ZJ, Zuo MX, Li JB, Huang JH, Huang ZL, Wu PH, Gu YK. Camrelizumab (a PD-1 inhibitor) plus apatinib (an VEGFR-2 inhibitor) and hepatic artery infusion chemotherapy for hepatocellular carcinoma in Barcelona Clinic Liver Cancer stage C (TRIPLET): a phase II study. Signal Transduct Target Ther. 2023 Oct 27;8(1):413. doi: 10.1038/s41392-023-01663-6. — View Citation

Zhu HD, Li HL, Huang MS, Yang WZ, Yin GW, Zhong BY, Sun JH, Jin ZC, Chen JJ, Ge NJ, Ding WB, Li WH, Huang JH, Mu W, Gu SZ, Li JP, Zhao H, Wen SW, Lei YM, Song YS, Yuan CW, Wang WD, Huang M, Zhao W, Wu JB, Wang S, Zhu X, Han JJ, Ren WX, Lu ZM, Xing WG, Fan Y, Lin HL, Zhang ZS, Xu GH, Hu WH, Tu Q, Su HY, Zheng CS, Chen Y, Zhao XY, Fang ZT, Wang Q, Zhao JW, Xu AB, Xu J, Wu QH, Niu HZ, Wang J, Dai F, Feng DP, Li QD, Shi RS, Li JR, Yang G, Shi HB, Ji JS, Liu YE, Cai Z, Yang P, Zhao Y, Zhu XL, Lu LG, Teng GJ; CHANCE001 Investigators. Transarterial chemoembolization with PD-(L)1 inhibitors plus molecular targeted therapies for hepatocellular carcinoma (CHANCE001). Signal Transduct Target Ther. 2023 Feb 8;8(1):58. doi: 10.1038/s41392-022-01235-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	1 year overall survival	1 year
Secondary	progression-free survival	1 year progression-free survival	1 year