Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063314) titled 'A Study on Early Stress and Inflammatory Dynamics for Predicting Outcomes in Immune Checkpoint Inhibitor Therapy' on Oct. 16.

Study Type: Observational

Primary Sponsor: Institute - Toranomon Hospital

Condition: Condition - Unresectable and Advanced Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate whether chronic stress status and early inflammatory dynamics are associated with treatment response and prognosis in unresectable or advanced cancer patients undergoing immune checkpoint inhibitor therapy. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with unresectable or advanced cancer confirmed to be clinically incurable, based on radiologic, histologic, or cytologic assessment. Patients receiving immune checkpoint inhibitor (ICI) therapy as first line treatment, either as monotherapy or in combination regimens, for metastatic, recurrent, or advanced disease. Prior surgery or radiotherapy is allowed, but patients who have received ICI as neoadjuvant or adjuvant therapy are excluded. Presence of evaluable disease according to RECIST version 1.1 measurable disease is not required. Patients aged 18 years or older, with no restrictions on sex. ECOG performance status (PS) 0 to 2. Written informed consent obtained from the patient after adequate explanation of the study prior to enrollment. Key exclusion criteria - Patients with severe comorbidities, including but not limited to severe infections, major cerebrovascular disease, poorly controlled diabetes, severe cardiac disease, interstitial lung disease or pulmonary fibrosis, active small bowel disease, severe hepatic impairment, or severe renal impairment. Patients scheduled to receive other forms of immunotherapy. Patients with synchronous or metachronous multiple malignancies, except for carcinoma in situ of the uterine cervix, adequately treated basal cell carcinoma of the skin, or malignancies treated more than 5 years earlier with no evidence of recurrence. Patients receiving continuous systemic corticosteroid therapy. Patients with coexisting autoimmune diseases. Patients with coexisting psychiatric disorders. Any patient deemed unsuitable for participation by the treating physician. Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 01 Day Date of IRB - 2026 Year 03 Month 18 Day Anticipated trial start date - 2026 Year 03 Month 18 Day Last follow-up date - 2029 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072469

Disclaimer: Curated by HT Syndication.