Tokyo, Nov. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059736) titled 'Multicenter Prospective Study of Early Predictive Biomarkers for the Efficacy of Nivolumab plus Ipilimumab in Unresectable Hepatocellular Carcinoma (HCC)' on Nov. 11.
Study Type:
Observational
Primary Sponsor:
Institute - Kindai University
Condition:
Condition - unresectable Hepatocellular Carcinoma
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To determine whether Fc gamma receptor polymorphisms (primary SNP: FCGR3A V158F) function as early predictive biomarkers of efficacy for nivolumab plus ipilimumab in unresectable HCC, within a multicenter prospective design with response assessors blinded to SNP information, and to define a clinically usable decision rule.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
= 2.
2.Child-Pugh class B or C.
3.Active autoimmune disease, or a history of autoimmune disease.
4.Active second primary malignancy, including any malignancy diagnosed within the past 5 years that has not been definitively cured.
5.Requirement for systemic immunosuppressive therapy.
6.Any patient deemed inappropriate by the principal investigator or sub-investigator for reasons of safety or scientific validity.
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 11 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067480
Disclaimer: Curated by HT Syndication.
