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

NCT05547516 | Unknown

• 1 other identifier: 2021ZDLSF02-16
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-muscle-invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor recurrence rate 1 year after surgery

  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 Outcomes (1)

• Observe postoperative complications (focus on side effects beyond standard perfusion therapy)

  from date of randomization until the date of first documented postoperative complications

Study Arms (2)

Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)

ACTIVE COMPARATOR

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

BL-5ALA-PDT

ACTIVE COMPARATOR

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; Procedure: BL - 5 ala PDT

Interventions

Standard infusion chemotherapy DRUG

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

Also known as: Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)

BL-5ALA-PDT; Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)

BL - 5 ala PDT PROCEDURE

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.

Also known as: Blue laser-5ala Photodynamic therapy

BL-5ALA-PDT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• According to the EORTC score of 5 or above;
• ≤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.

You may not qualify if:

• Patients with severe systemic diseases (such as severe coagulation disorders, decompensation of important organ functions) or chronic wasting diseases;
• The patient has a history of other malignant tumors in the past five years;
• Pregnant and lactating women;
• Those who have undergone major surgery within 1 month before enrollment;
• Participate in other clinical trials;
• Other conditions (such as: mental illness, etc.) considered inappropriate by the researcher.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

Dalin He

Xi'an, Shaanxi, 710061, China

Location

Related Publications (6)

• Babjuk M, Burger M, Comperat EM, Gontero P, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Sylvester R, Zigeuner R, Capoun O, Cohen D, Escrig JLD, Hernandez V, Peyronnet B, Seisen T, Soukup V. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update. Eur Urol. 2019 Nov;76(5):639-657. doi: 10.1016/j.eururo.2019.08.016. Epub 2019 Aug 20.

  PMID: 31443960 BACKGROUND

• Messing EM, Tangen CM, Lerner SP, Sahasrabudhe DM, Koppie TM, Wood DP Jr, Mack PC, Svatek RS, Evans CP, Hafez KS, Culkin DJ, Brand TC, Karsh LI, Holzbeierlein JM, Wilson SS, Wu G, Plets M, Vogelzang NJ, Thompson IM Jr. Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1880-1888. doi: 10.1001/jama.2018.4657.

  PMID: 29801011 BACKGROUND

• Agostinis P, Berg K, Cengel KA, Foster TH, Girotti AW, Gollnick SO, Hahn SM, Hamblin MR, Juzeniene A, Kessel D, Korbelik M, Moan J, Mroz P, Nowis D, Piette J, Wilson BC, Golab J. Photodynamic therapy of cancer: an update. CA Cancer J Clin. 2011 Jul-Aug;61(4):250-81. doi: 10.3322/caac.20114. Epub 2011 May 26.

  PMID: 21617154 BACKGROUND

• Railkar R, Agarwal PK. Photodynamic Therapy in the Treatment of Bladder Cancer: Past Challenges and Current Innovations. Eur Urol Focus. 2018 Jul;4(4):509-511. doi: 10.1016/j.euf.2018.08.005. Epub 2018 Aug 23.

  PMID: 30145112 BACKGROUND

• Kushibiki T, Hirasawa T, Okawa S, Ishihara M. Blue laser irradiation generates intracellular reactive oxygen species in various types of cells. Photomed Laser Surg. 2013 Mar;31(3):95-104. doi: 10.1089/pho.2012.3361. Epub 2013 Feb 7.

  PMID: 23390956 BACKGROUND

• Ericson MB, Grapengiesser S, Gudmundson F, Wennberg AM, Larko O, Moan J, Rosen A. A spectroscopic study of the photobleaching of protoporphyrin IX in solution. Lasers Med Sci. 2003;18(1):56-62. doi: 10.1007/s10103-002-0254-2.

  PMID: 12627275 BACKGROUND

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Mitomycin; Epirubicin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Dalin He, Dr.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalin He, Dr.

CONTACT

13991288221; hedl@mail.xjtu.edu.cn

Kaijie Wu, Dr.

CONTACT

15389299128; kaijie_wu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: September 13, 2022
• Primary Completion: September 13, 2022
• Study Completion: February 1, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

CN (1)