Trial Title:
Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
NCT ID:
NCT05547516
Condition:
Non-muscle-invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Gemcitabine
Epirubicin
Mitomycins
Mitomycin
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Standard infusion chemotherapy
Description:
standard infusion chemotherapy (including gemcitabine, mitomycin, epirubicin, etc.),
dissolved in 50mL normal saline or glucose, intravesical infusion chemotherapy, retained
for 60min. Perfusion can be performed within 24 hours after surgery, and then once a week
for a total of 8 times, and then once a month until 12 months after surgery
Arm group label:
BL-5ALA-PDT
Arm group label:
Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)
Other name:
Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)
Intervention type:
Procedure
Intervention name:
BL - 5 ala PDT
Description:
BL - 5 ala PDT - plan: 5ALA 1.5g (Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd),
dissolved in 50mL normal saline, was infused into the bladder for 2 hours before surgery
and before each cystoscopy. Blue laser irradiation was performed under a flexible
cystoscope at 30mW/cm2 for 21min. PDT was performed during the operation and at 3, 6, and
9 months after the operation.
Arm group label:
BL-5ALA-PDT
Other name:
Blue laser-5ala Photodynamic therapy
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dalin He
Address:
City:
Xi'an
Zip:
710061
Country:
China
Contact:
Last name:
Dalin He, Dr.
Phone:
13991288221
Email:
hedl@mail.xjtu.edu.cn
Contact backup:
Last name:
Kaijie Wu, Dr.
Phone:
15389299128
Email:
kaijie_wu@163.com
Start date:
September 13, 2022
Completion date:
February 1, 2024
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05547516
