Tokyo, July 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062259) titled 'Clinical Outcomes and Safety of Perioperative Durvalumab Plus Gemcitabine-Cisplatin Therapy for Muscle-Invasive Bladder Cancer: A Study at Shinshu University and Kagawa University' on July 16.
Study Type:
Observational
Primary Sponsor:
Institute - Shinshu University
Condition:
Condition - Muscle-Invasive Bladder Cancer (MIBC)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the real-world effectiveness and safety of perioperative durvalumab plus GC therapy for muscle-invasive bladder cancer at Shinshu University and Kagawa University.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 18
years-old
18 years, regardless of sex.
2. Clinically diagnosed muscle-invasive bladder cancer (cT2-4a, N0/1, M0).
3. Histologically confirmed urothelial carcinoma, irrespective of the presence of variant histology.
4. Judged to be clinically eligible for radical cystectomy with curative intent.
5. No prior treatment with systemic chemotherapy.
6. No severe renal dysfunction, defined as eGFR or creatinine clearance >40 mL/min.
7. Scheduled to undergo perioperative durvalumab plus gemcitabine/cisplatin (GC) therapy.
Key exclusion criteria - 1. Histological subtypes other than urothelial carcinoma, including squamous cell carcinoma and adenocarcinoma.
2. Active autoimmune disease.
3. Known hypersensitivity or allergy to any of the study drugs.
4. Refusal of data sharing/provision by the patient or the patient's family.
5. Any other condition that, in the judgment of the principal investigator, renders the patient unsuitable for participation in the study.
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 01 Month 10 Day
Date of IRB - 2026 Year 03 Month 08 Day
Anticipated trial start date - 2026 Year 03 Month 17 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069683
Disclaimer: Curated by HT Syndication.
