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Trial record 22 of 26 for:    upper tract urothelial

Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099589
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jianzhong Shou, 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.

Condition or disease Intervention/treatment Phase
Upper Tract Urinary Carcinoma Muscle Invasive Bladder Cancer Drug: Toripalimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group 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 : October 1, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Toripalimab 240mg injection, every 21 days for 2-4 cycles
Drug: Toripalimab
Gemcitabine/Cisplatin plus Toripalimab




Primary Outcome Measures :
  1. pathological complete response rate [ Time Frame: through study completion of 3 years ]
    the percentage of pT0N0 patients after operations



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. bladder cancer of T2-4aN0M0
  2. upper tract urinary carcinoma of T1-3N0M0
  3. 18-70 years old
  4. ECOG 0-1
  5. good organ function
  6. no previous chemotherapy or immunotherapy
  7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099589


Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Jianzhong Shou, MD    13601332989    shoujzh@126.com   
Sponsors and Collaborators
Jianzhong Shou

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Responsible Party: Jianzhong Shou, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04099589     History of Changes
Other Study ID Numbers: NCC2121
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs