NCT04553939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2025

Completed
Last Updated

January 2, 2026

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

September 13, 2020

Last Update Submit

December 30, 2025

Conditions

Urothelial CarcinomaBladder Cancer

Keywords

ToripalimabNeoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • ORR，objective response rate

    ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) based upon RECIST 1.1.

    3 years

Study Arms (1)

Toripalimab in Combination With Gemcitabine Therapy

EXPERIMENTAL
Drug: ToripalimabDrug: Gemcitabine

Interventions

ToripalimabDRUG

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

Toripalimab in Combination With Gemcitabine Therapy
GemcitabineDRUG

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

Toripalimab in Combination With Gemcitabine Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing and able to provide written informed consent for the trial.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Related Publications (5)

  • von der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, Moore MJ, Zimmermann A, Arning M. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005 Jul 20;23(21):4602-8. doi: 10.1200/JCO.2005.07.757.

    PMID: 16034041BACKGROUND

  • Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

    PMID: 29658848BACKGROUND

  • Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, Plimack ER, Hahn NM, de Wit R, Pang L, Savage MJ, Perini RF, Keefe SM, Bajorin D, Bellmunt J. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Nov;18(11):1483-1492. doi: 10.1016/S1470-2045(17)30616-2. Epub 2017 Sep 26.

    PMID: 28967485BACKGROUND

  • Wang Z, Till B, Gao Q. Chemotherapeutic agent-mediated elimination of myeloid-derived suppressor cells. Oncoimmunology. 2017 Jun 16;6(7):e1331807. doi: 10.1080/2162402X.2017.1331807. eCollection 2017.

    PMID: 28811975BACKGROUND

  • Galluzzi L, Zitvogel L, Kroemer G. Immunological Mechanisms Underneath the Efficacy of Cancer Therapy. Cancer Immunol Res. 2016 Nov;4(11):895-902. doi: 10.1158/2326-6066.CIR-16-0197.

    PMID: 27803050BACKGROUND

MeSH Terms

Conditions

Carcinoma, Transitional CellUrinary Bladder Neoplasms

Interventions

toripalimabGemcitabine

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • zhao Shiming

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2020

First Posted

September 18, 2020

Study Start

January 4, 2021

Primary Completion

April 12, 2023

Study Completion

April 12, 2025

Last Updated

January 2, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)