Clinical trial NCT05547516: Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study of Blue Laser-5ALA-photodynamic Therapy (PDT) in the Prevention of Postoperative Tumor Recurrence in High-risk Non-muscle-invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-muscle-invasive Bladder Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Detailed Description:

1. Overall Study Design and Plan: a multicenter prospective randomized controlled clinical study;
2. Research steps: clinical recruitment, random enrollment, surgical treatment, regular postoperative preventive adjuvant intervention treatment + follow-up observation, and statistical analysis.
3. Screening Period: After obtaining the consent of the hospital ethics committee, the recruitment advertisement will be published to start the recruitment. September 1, 2022 to February 28, 2023, with at least one year follow-up. By reviewing inclusion and exclusion criteria, patients will be eligible to participate in the study. A total of 140 patients were recruited: 70 patients received conventional postoperative infusion chemotherapy (control group), and 70 patients received conventional postoperative infusion chemotherapy combined with BL-5ALA-PDT (BL-5ALA-PDT group).
4. Study Drug and PDT Administration: TURB-t uses the plasma resectoscope produced by Japan Olympus Company, and uses standardized layered electric resection or laser ablation surgical techniques; BL-5ALA-PDT uses Xi'an Lanji Medical Electronic Technology Co., Ltd. (The semiconductor laser therapeutic apparatus produced by Xi'an) was used as the PDT excitation light source, and 5ALA was purchased from Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co., Ltd.
5. Postoperative infusion treatment plan: standard infusion chemotherapy (including gemcitabine, mitomycin, epirubicin, etc.), dissolved in 50 mL of normal saline or glucose, and intravesical infusion chemotherapy for 60 minutes. Perfusion can be done within 24 hours after operation, then once a week, a total of 8 times, and then changed to once a month to 12 months after operation; BL-5ALA-PDT program: 1.5g of 5ALA (Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co., Ltd) was dissolved in 50 mL of normal saline, and infused into the bladder for 2 hours before surgery and before each cystoscopy. Blue laser irradiation was carried out at 30mW/cm2 and 21min under irradiation. PDT was performed during the operation and at 3, 6, and 9 months after the operation.
6. Postoperative follow-up plan: review urine routine, urinary B-ultrasound and cystoscopy in at 3, 6, and 9 months after operation, and record the follow-up in the follow-up registry at the same time. Follow-up content: urine routine, urinary B-ultrasound and cystoscopy results.
7. Evaluation indicators:

Main Outcome: Tumor recurrence rate 1 year after surgery Secondary Outcome: Observe postoperative complications (focus on side effects beyond standard perfusion therapy)

Eligibility 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.

Primary outcomes:
measure: Tumor recurrence rate 1 year after surgery
timeFrame: from date of randomization until the date of first documented Tumor recurrence
Secondary outcomes:
measure: Observe postoperative complications (focus on side effects beyond standard perfusion therapy)
timeFrame: from date of randomization until the date of first documented postoperative complications
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dalin He
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of Xi 'an Jiaotong University
name: Dalin He, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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