HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

NCT06327932 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HIVEC(PRG)
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).

Conditions

Non-Muscle-Invasive Bladder Cancer

Keywords

Non-Muscle-Invasive Bladder Cancer; Hyperthermic Intravesical Chemotherapy; recurrence rate

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases \* 100%.

  2-year

Secondary Outcomes (6)

• 1-year recurrence rate

  1-year

• Recurrence-free survival (RFS) rate

  2-year

• Time to treatment failure

  2-year

• Success rate of therapeutic operation

  2-year

• Quality of international prostate symptom score

  Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.

Study Arms (2)

Matched control

ACTIVE COMPARATOR

Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.

Procedure: TURBT; Procedure: Intravesical Chemotherapy; Drug: Gemcitabine

HIVEC

EXPERIMENTAL

Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)

Procedure: TURBT; Procedure: HIVEC; Drug: Gemcitabine

Interventions

TURBT PROCEDURE

Transurethral Resection of Bladder Tumors

HIVEC; Matched control

HIVEC PROCEDURE

Hyperthermic Intravesical Chemotherapy with Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes. Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.

HIVEC

Intravesical Chemotherapy PROCEDURE

Intravesical Chemotherapy with Gemcitabine (3g/150ml NS). Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.

Matched control

Gemcitabine DRUG

Gemcitabine (3g/150ml NS).

HIVEC; Matched control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time).
• Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors).
• KPS score ≥80, expected survival \> 30 months.
• Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
• Age between 18 and 70 years, all genders.
• Volunteer to participate in this clinical trial and written informed consent.

You may not qualify if:

• Patients with bladder cancer in situ.
• Combined with proven upper urinary tract or urethral tumors.
• The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
• Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.
• Patients who had undergone partial cystectomy or abnormal bladder structure were judged by the investigator to be unsuitable for perfusion therapy.
• Patients with severe coagulation dysfunction.
• A history of allergy to injected drugs (gemcitabine).
• History of pelvic radiation, systemic chemotherapy, or immunotherapy.
• Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and other serious diseases.
• Patients with mental illness, substance abuse, alcoholism, and inability to cooperate.
• Breastfeeding, pregnant, or planning to have a baby in the near future.
• Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
• Participated in other clinical trials 1 month before the trial.
• Vesicoureteral regurgitation.
• The investigator considered it inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shuzhong Cui, MD

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuzhong Cui, MD

CONTACT

020-66673666; cuishuzhong@gzhmu.edu

Jing Li, MD

CONTACT

020-66673666; lijingzlyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 25, 2024

Record last verified: 2024-03