Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer

Phase II Study of Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Stage II-IIIB Bladder Cancer

Sponsors

Lead Sponsor: Henan Cancer Hospital

Source Henan Cancer Hospital
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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date December 2023
Primary Completion Date May 2023
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
ORR,objective response rate 3 years
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Toripalimab

Description: Toripalimab 3mg/m2 ivgtt, D1 every 14 days for 2-4 cycles.

Arm Group Label: Toripalimab in Combination With Gemcitabine Therapy

Intervention Type: Drug

Intervention Name: Gemcitabine

Description: Gemcitabine 800mg/m2 ivgtt, D1 every 14 days for 2-4 cycles.

Arm Group Label: Toripalimab in Combination With Gemcitabine Therapy

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

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
zhao Shiming Principal Investigator Henan Cancer Hospital
Overall Contact

Last Name: Zhao Shiming

Phone: 008618638697090

Email: [email protected]

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Toripalimab in Combination With Gemcitabine Therapy

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov