Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 29, 2022
March 1, 2022
3 years
September 19, 2019
March 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pathological complete response rate
the percentage of pT0N0 patients after operations
through study completion of 3 years
Study Arms (2)
MIBC Group
EXPERIMENTALMuscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.
UTUC Group
EXPERIMENTALUpper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.
Interventions
Eligibility Criteria
You may qualify if:
- bladder cancer of T2-4aN0M0
- upper tract urinary carcinoma of T1-3N0M0 and high grade
- ECOG 0-1
- good organ function
- no previous chemotherapy or immunotherapy
- Informed consent form signed
You may not qualify if:
- unable to receive chemotherapy or surgery due to physical abnormalities
- previous cancer history
- active tuberculosis
- HIV
- autoimmune disease
- anticipating other clinical studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Jianzhong Shou
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 23, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
March 29, 2022
Record last verified: 2022-03