Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
Conditions
Interventions
Intervention1: dose dense cisplatin with methotrexate with vinblastine with serplulimab: Cisplatin 70mg per m2 iv every 2 weeks for 6 cycles
Methotrexate 30mg per m2 iv every 2 weeks for 6 cycles Vinb
Sponsors
Christian medical college, Vellore
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults more than or equal to 18 years of age 2. Histological confirmation of urothelial carcinoma of the bladder or squamous cell carcinoma or mixed (urothelial with squamous) 3. Clinical AJCC 8 stage cT2 to T4 N1 to N2, non metastatic 4. Determined to be medically suitable for radical cystectomy 5. ECOG of less than 2 6. NYHA class 2 or less 7. Written informed consent obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study
Exclusion criteria
Exclusion criteria: 1. Pregnant breastfeeding or unwilling to practice birth control during participation in the study 2.Documented baseline neuropathy CTCAE verion 5 grade more than equal to 2 3. Creatinine clearance less than 40ml/min 4. Documented baseline audiometry suggestive of hearing loss CTCAE version 5 grade more than or equal to 2 5. Inoperable tumor 6. Non regional nodes more than or equal to 10mm in short axis 7. History of an autoimmune disease requiring at least more than 10mg of prednisolone per day 8. Hypersensitivity to drugs in the trial 9. Live vaccine administration within 30 days 10. Underwent major surgery within 28 days 11. History of prior pelvic radiation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate which is percentage of patients achieving pathological staging of T0N0M0 after neoadjuvant treatment, determined from cystectomy specimenTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survivalTimepoint: 2 years;Treatment completion rateTimepoint: 16 weeks;Total cystectomy rateTimepoint: 16 weeks;More than or equal to Grade 3 adverse event rateTimepoint: At the start of each cycle of chemotherapy;Overall survivalTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactASHISH SINGH
Christian medical college, Vellore
Outcome results
None listed