Clinical trial · Interventional

HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intravesical Chemotherapy After Transurethral Resection of Bladder Tumors in Patients With Non-Muscle-Invasive Bladder Cancer

NCT06327932CI-TRIAL-00075358not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-Muscle-Invasive Bladder Cancer	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Gemcitabine	Drug	Gemcitabine	ALIAS
HIVEC	Procedure	—	UNRESOLVED
Intravesical Chemotherapy	Procedure	—	UNRESOLVED
TURBT	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Matched control
description
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy.
interventionNames
1. Procedure: TURBT
2. Procedure: Intravesical Chemotherapy
3. Drug: Gemcitabine
type
EXPERIMENTAL
label
HIVEC
description
Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC)
interventionNames
1. Procedure: TURBT
2. Procedure: HIVEC
3. Drug: Gemcitabine

Primary outcomes (1)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

1. 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).
2. 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).
3. KPS score ≥80, expected survival \> 30 months.
4. Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
5. Age between 18 and 70 years, all genders.
6. Volunteer to participate in this clinical trial and written informed consent.

Exclusion Criteria:

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

References

Publications (0)

Data not yet available

No reference posted for this study.