Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059241) titled 'A Multicenter Prospective Registry of Systemic Therapy for Unresectable Hepatocellular Carcinoma with Linked Multi-omics Biobanking and Translational Validation' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - Hepatocellular Carcinoma
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To elucidate predictors of therapeutic efficacy for each pharmacologic treatment of hepatocellular carcinoma and to identify clinically useful blood-based and histopathologic biomarkers. We will prospectively register all patients with HCC who are indicated for systemic therapy at Osaka University and collaborating institutions nationwide in a centralized database, collect clinical, hematologic, and histopathologic data obtained before and after treatment initiation, and analyze their associations with antitumor response and clinical outcomes.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients aged over 20 years
2. Life expectancy of >12 weeks
3. Hepatocellular carcinoma diagnosed by histology, cytology or by imaging such as dynamic contrast enhanced CT or MRI
4. Not amenable to locoregional therapy and eligible for systemic pharmacotherapy
5. ECOG Performance Status 0 or 1
6. No contraindications to the planned agents per the approved package insertm, prescribing information
Key exclusion criteria - 1. Patients from whom informed consent cannot be obtained
2. Patients deemed unsuitable for the study by the principal investigator or a subinvestigator
Target Size - 1000
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 09 Month 30 Day
Date of IRB - 2025 Year 09 Month 12 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2032 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067756
Disclaimer: Curated by HT Syndication.