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Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Primary Purpose

Upper Tract Urinary Carcinoma, Muscle-invasive Bladder Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Tract Urinary Carcinoma focused on measuring upper tract urinary carcinoma, muscle-invasive bladder cancer, neoadjuvant, chemotherapy, immunotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MIBC Group

UTUC Group

Arm Description

Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.

Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.

Outcomes

Primary Outcome Measures

pathological complete response rate
the percentage of pT0N0 patients after operations

Secondary Outcome Measures

Full Information

First Posted
September 19, 2019
Last Updated
March 12, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Peking University First Hospital, China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04099589
Brief Title
Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Peking University First Hospital, China-Japan Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Tract Urinary Carcinoma, Muscle-invasive Bladder Cancer
Keywords
upper tract urinary carcinoma, muscle-invasive bladder cancer, neoadjuvant, chemotherapy, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIBC Group
Arm Type
Experimental
Arm Description
Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients.
Arm Title
UTUC Group
Arm Type
Experimental
Arm Description
Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
Gemcitabine/Cisplatin plus Toripalimab
Primary Outcome Measure Information:
Title
pathological complete response rate
Description
the percentage of pT0N0 patients after operations
Time Frame
through study completion of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: unable to receive chemotherapy or surgery due to physical abnormalities previous cancer history active tuberculosis HIV autoimmune disease anticipating other clinical studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianzhong Shou
Phone
86-18813019104
Email
chuanzhenc@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhong Shou
Organizational Affiliation
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Shou, MD
Phone
13601332989
Email
shoujzh@126.com

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

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