Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062598) titled 'Multicenter Prospective Observational Study of Immune Checkpoint Inhibitor Rechallenge After Recovery From Severe ICI-Induced Liver Injury' on Aug. 18.

Study Type: Observational

Primary Sponsor: Institute - Nagoya University

Condition: Condition - Patients with malignancies who experienced Grade 3 or higher immune checkpoint inhibitor-induced liver injury Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively follow patients who have recovered from Grade 3 or higher ICI-induced liver injury and undergo ICI rechallenge as part of routine clinical care, and to evaluate the recurrence rate of Grade 2 or higher ICI-induced liver injury within 6 months after rechallenge, the severity of recurrent liver injury, other immune-related adverse events, and antitumor efficacy. The study will also explore factors associated with the risk of liver injury recurrence using clinical data, blood biomarkers, and liver biopsy findings. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Age 18 years or older 2) History of ICI treatment for a malignant tumor 3) Recovery after grade 3 or higher ICI-induced liver injury 4) The treating physician or clinical team has carefully assessed the risks and benefits and determined that ICI retreatment is clinically appropriate Key exclusion criteria - Patients who do not provide written informed consent to participate in the study Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 04 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2031 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071239

Disclaimer: Curated by HT Syndication.