Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients

• Status: Not yet recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This project will conduct a large-sample, multi-center prospective clinical trial to further establish the safety and efficacy of BL-5ALA-PDT in preventing Non-Muscle Invasive Bladder Cancer (NMIBC) recurrence when compared to the usual postoperative perfusion chemotherapy regimen.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Epirubicin; Gemcitabine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

1. Pathologically determined as high-risk NMIBC (meet any of the following: ①T1 stage tumor; ②G3 or high-grade urothelial carcinoma; ③CIS; cancer), patients planning to undergo transurethral surgery;

2. According to the EORTC score of 5 or above;

3. 18≤age≤80 years old, according to the requirements of the ethics committee, the patients (or authorized principals) agree to participate in this experiment and sign the informed consent.

Exclusion Criteria:

1. Patients with severe systemic diseases (such as severe coagulation disorders, decompensation of important organ functions) or chronic wasting diseases;

2. The patient has a history of other malignant tumors in the past five years;

3. Pregnant and lactating women;

4. Those who have undergone major surgery within 1 month before enrollment;

5. Participate in other clinical trials;

6. Other conditions (such as: mental illness, etc.) considered inappropriate by the researcher.