Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04099589
Collaborator
Peking University First Hospital (Other), China-Japan Friendship Hospital (Other)
64
1
2
36
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MIBC Group

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

Drug: Toripalimab
Gemcitabine/Cisplatin plus Toripalimab

Experimental: UTUC Group

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

Drug: Toripalimab
Gemcitabine/Cisplatin plus Toripalimab

Outcome Measures

Primary Outcome Measures

  1. pathological complete response rate [through study completion of 3 years]

    the percentage of pT0N0 patients after operations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021

Sponsors and Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Peking University First Hospital
  • China-Japan Friendship Hospital

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianzhong Shou, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04099589
Other Study ID Numbers:
  • NCC2121
First Posted:
Sep 23, 2019
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
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
Keywords provided by Jianzhong Shou, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022