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

September 19, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)
Standard infusion chemotherapy (including gemcitabine, mitomycin, epirubicin, etc.) was dissolved in 50mL normal saline or glucose and perfused into the bladder 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.
Drug: Standard infusion chemotherapy
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
Other Names:
  • Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)
ACTIVE_COMPARATOR: BL-5ALA-PDT
Bl-5ala-pdt protocol: 1.5g 5ALA, dissolved in 50mL normal saline, was infused into the bladder for 2h before surgery and before each cystoscopy, and blue laser irradiation was performed under flexible cystoscopy at 30mW/cm2 for 21min. PDT was performed during the operation and at 3, 6, and 9 months after the operation.
Drug: Standard infusion chemotherapy
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
Other Names:
  • Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)
Procedure: BL - 5 ala PDT
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.
Other Names:
  • Blue laser-5ala Photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor recurrence rate 1 year after surgery
Time Frame: from date of randomization until the date of first documented Tumor recurrence
The recurrence rate of NMBC at 1 year after surgery was evaluated by regular urine routine, urinary B-ultrasound and cystoscopy
from date of randomization until the date of first documented Tumor recurrence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe postoperative complications (focus on side effects beyond standard perfusion therapy)
Time Frame: from date of randomization until the date of first documented postoperative complications
postoperative complications were evaluated by regular urine routine, urinary B-ultrasound and cystoscopy
from date of randomization until the date of first documented postoperative complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Dalin He, Dr., The First Affiliated Hospital of Xi 'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 13, 2022

Primary Completion (ANTICIPATED)

September 13, 2022

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (ACTUAL)

September 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021ZDLSF02-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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