Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer (HIGCrecur)

March 16, 2025 updated by: Shuxiong Zeng, Changhai Hospital

Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bladder cancer ranks as the ninth most prevalent cancer globally, with urothelial carcinoma being the primary form, leading to over 220,000 deaths annually. While 70-75% of bladder cancer cases initially present as non-muscle invasive bladder cancer (NMIBC) with favorable prognoses, the recurrence rate can reach 78% within five years post-standard treatment. The primary objective of transurethral resection of bladder tumors (TURBT) is to accurately diagnose and completely eliminate all visible lesions, as the quality of resection significantly impacts prognosis. However, a systematic review reveals a notable risk of residual tumor post-initial resection. For individuals with high-risk non-muscle invasive bladder cancer (NMIBC), EAU guidelines recommend a follow-up resection 2-6 weeks later. Clinical trials have demonstrated that administering a single chemotherapy session within 24 hours of the initial resection can lower recurrence rates. This approach may work by eradicating floating tumor cells, ablating residual tumor cells, and addressing overlooked small tumors. Gemcitabine and cisplatin (GC) have good efficacy and tolerance in patients with bladder cancer and have become the most commonly used regimen in the neoadjuvant treatment of bladder cancer. There is currently a lack of strong evidence that GC chemotherapy 24 hours after surgery can safely and effectively reduce the risk of recurrence in suspected high-risk NMIBC cases. Our goal is to conduct a prospective clinical trial to investigate the feasibility of this treatment method by evaluating the incidence of adverse events and recurrence-free survival in this group of patients by administering systemic chemotherapy 24 hours after TURBT for patients with suspected high-recurrence bladder cancer.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shuxiong Zeng, M.D. Ph.D
  • Phone Number: +8618930568759 +8618930568759
  • Email: zengshuxiong@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate GC chemotherapy infusion
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
Systemic chemotherapy with cisplatin/gemcitabine intravenous infusion within 24 hours after TURBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year recurrence-free survival rate
Time Frame: About two years after the first immediate chemotherapy
The percentage of patients who remain cancer-free for one year after treatment.
About two years after the first immediate chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological downstaging rate
Time Frame: About 2-6 weeks after the first immediate chemotherapy
The percentage of patients whose cancer has decreased in stage following treatment.
About 2-6 weeks after the first immediate chemotherapy
The incidence of grade ≥ 3 adverse events（AEs）
Time Frame: About two years after the first immediate chemotherapy
The frequency of severe or serious side effects experienced by patients during a clinical trial or medical treatment(CTCAE V5.0 ).
About two years after the first immediate chemotherapy
UroCAD.MRD Index
Time Frame: TURBT perioperative period, about 15 days
Body fluid samples were collected from patients before and after TUBRT and chemotherapy for chromosomal instability testing, and the residual tumor status of patients was analyzed by analyzing the changes in the UroCAD.MRD index.
TURBT perioperative period, about 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Shuxiong Zeng, M.D. Ph.D, Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-Urology-NAC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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