Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Phase 2

• Conditions: Muscle-invasive Bladder Cancer; Upper Tract Urinary Carcinoma
• Interventions: Drug: Toripalimab

• Registration Number: NCT04099589
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Study Start: 2019-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-12
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. bladder cancer of T2-4aN0M0
2. upper tract urinary carcinoma of T1-3N0M0 and high grade
3. ECOG 0-1
4. good organ function
5. no previous chemotherapy or immunotherapy
6. Informed consent form signed

Exclusion Criteria

1. unable to receive chemotherapy or surgery due to physical abnormalities
2. previous cancer history
3. active tuberculosis
4. HIV
5. autoimmune disease
6. anticipating other clinical studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIBC Group	Toripalimab	Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.
UTUC Group	Toripalimab	Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.

Primary Outcome Measures

Name	Time	Method
pathological complete response rate	through study completion of 3 years	the percentage of pT0N0 patients after operations

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China