Brief Title
Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer
Official Title
Phase II Study of Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Stage II-IIIB Bladder Cancer
Brief Summary
This is a pre-surgical study involving subjects with muscle invasive bladder urothelial
cancer, who are candidates for cisplatin ineligible neoadjuvant therapy. It is a one-arm
phase II study in single center.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
ORR，objective response rate
Condition
Urothelial Carcinoma
Intervention
Toripalimab
Study Arms / Comparison Groups
Toripalimab in Combination With Gemcitabine Therapy
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
January 4, 2021
Completion Date
December 2023
Primary Completion Date
May 2023
Eligibility Criteria
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial.
- 18-75 years of age on day of signing informed consent.
- Have histologically confirmed muscle invasive disease of the urinary bladder.
- Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial
carcinoma with mixed histology/features.
- Clinical stage II-IIIB and Have a surgical evaluation that documents the plan for
multimodality therapy with a consolidative radical cystectomy.
- ECOG 0-1 and good organ function.
- cisplatin ineligible.
Exclusion Criteria:
- A non-surgical approach recommended by the treating urologist due to any reason.
- Is currently participating in or has participated in a study of an investigational
agent or using an investigational device within 28 days prior to study registration.
- Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other
form of immunosuppressive therapy within 7 days prior to study registration.
- Has a known additional malignancy that is progressing or required treatment ≤ 48
months of study registration. Exceptions include basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Has an active autoimmune disease requiring systemic treatment.
- Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's
participation for the full duration of the trial, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, antibody.
- Has a known history of Human Immunodeficiency Virus.
- Has known active Hepatitis B or Hepatitis C.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
zhao Shiming, 008618638697090, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04553939
Organization ID
2020051314
Responsible Party
Sponsor
Study Sponsor
Henan Cancer Hospital
Study Sponsor
zhao Shiming, Principal Investigator, Henan Cancer Hospital
Verification Date
September 2021