NCT06889623

Brief Summary

Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress48%
Jun 2024Jun 2028

Study Start

First participant enrolled

June 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 16, 2025

Last Update Submit

March 16, 2025

Conditions

NMIBC

Outcome Measures

Primary Outcomes (1)

  • One-year recurrence-free survival rate

    The percentage of patients who remain cancer-free for one year after treatment.

    About two years after the first immediate chemotherapy

Secondary Outcomes (3)

  • Pathological downstaging rate

    About 2-6 weeks after the first immediate chemotherapy

  • The incidence of grade ≥ 3 adverse events（AEs）

    About two years after the first immediate chemotherapy

  • UroCAD.MRD Index

    TURBT perioperative period, about 15 days

Study Arms (1)

Immediate GC chemotherapy infusion

EXPERIMENTAL

For enrolled patients receiving immediate cisplatin/gemcitabine chemotherapy via intravenous infusion within 24 hours post transurethral resection of bladder tumor (TURBT), fluid samples were collected before and after TURBT, as well as post-chemotherapy, for UroCAD testing to assess chromosomal instability status and evaluate postoperative tumor residual changes. Subsequently, following EAU guidelines, patients were administered 1 year of intravesical Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, with regular imaging studies and cystoscopic examinations for follow-up to assess the patients' pathological response status.

Procedure: Immediate postoperative chemotherapy

Interventions

Immediate postoperative chemotherapyPROCEDURE

Systemic chemotherapy with cisplatin/gemcitabine intravenous infusion within 24 hours after TURBT

Immediate GC chemotherapy infusion

Eligibility Criteria

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

You may qualify if:

  • Patients with a history and cystoscopy results indicating high-risk NMIBC:
  • High-grade T1
  • Any recurrent high-grade Ta
  • High-grade Ta \& Tumor diameter greater than 3 cm or multifocal
  • Any CIS
  • Any BCG failure in patients with high-grade disease
  • Any variant histology
  • Any LVI
  • Any high-grade prostatic urethral involvement
  • Patients in generally good condition with a follow-up period of 2 years

You may not qualify if:

  • Bladder cancer other than UC
  • MIBC or benign diseases
  • Incomplete tumor resection
  • Active infection
  • Concurrent upper urinary tract or prostatic urethral UC
  • Previous systemic chemotherapy, immunotherapy, or radiotherapy
  • Leukopenia/thrombocytopenia
  • Serum creatinine greater than twice the normal level
  • Uncontrollable urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (5)

  • Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10.

    PMID: 34511303BACKGROUND

  • Flaig TW, Tangen CM, Daneshmand S, Alva AS, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr, Lerner SP. Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695). Eur Urol. 2023 Sep;84(3):341-347. doi: 10.1016/j.eururo.2023.06.014. Epub 2023 Jul 4.

    PMID: 37414705BACKGROUND

  • Bosschieter J, Nieuwenhuijzen JA, van Ginkel T, Vis AN, Witte B, Newling D, Beckers GMA, van Moorselaar RJA. Value of an Immediate Intravesical Instillation of Mitomycin C in Patients with Non-muscle-invasive Bladder Cancer: A Prospective Multicentre Randomised Study in 2243 patients. Eur Urol. 2018 Feb;73(2):226-232. doi: 10.1016/j.eururo.2017.06.038. Epub 2017 Jul 10.

    PMID: 28705539BACKGROUND

  • Pfister C, Gravis G, Flechon A, Chevreau C, Mahammedi H, Laguerre B, Guillot A, Joly F, Soulie M, Allory Y, Harter V, Culine S; VESPER Trial Investigators. Perioperative dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin in muscle-invasive bladder cancer (VESPER): survival endpoints at 5 years in an open-label, randomised, phase 3 study. Lancet Oncol. 2024 Feb;25(2):255-264. doi: 10.1016/S1470-2045(23)00587-9. Epub 2023 Dec 21.

    PMID: 38142702BACKGROUND

  • Messing EM, Tangen CM, Lerner SP, Sahasrabudhe DM, Koppie TM, Wood DP Jr, Mack PC, Svatek RS, Evans CP, Hafez KS, Culkin DJ, Brand TC, Karsh LI, Holzbeierlein JM, Wilson SS, Wu G, Plets M, Vogelzang NJ, Thompson IM Jr. Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1880-1888. doi: 10.1001/jama.2018.4657.

    PMID: 29801011BACKGROUND

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shuxiong Zeng, M.D. Ph.D

    Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuxiong Zeng, M.D. Ph.D

CONTACT

+8618930568759zengshuxiong@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A.P

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 21, 2025

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)