Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Muscle-invasive Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04099589
• Other study ID #: NCC2121
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jianzhong Shou
• Phone: 86-18813019104
• Email: chuanzhenc[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Muscle-invasive Bladder Cancer
• Upper Tract Urinary Carcinoma
• Urinary Bladder Neoplasms

Intervention

Drug:
• Toripalimab
Gemcitabine/Cisplatin plus Toripalimab

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response rate	the percentage of pT0N0 patients after operations	through study completion of 3 years