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

Naval Military Medical University

Status: Enrolling

Conditions: NMIBC

Treatments: Procedure: Immediate postoperative chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06889623

CH-Urology-NAC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Immediate GC chemotherapy infusion

Experimental group

Description:

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.

Treatment:

Procedure: Immediate postoperative chemotherapy