Non-muscle-invasive Bladder CancerBL-PDT-RCTNCT05547516
Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
A study testing Standard infusion chemotherapy and BL - 5 ala PDT in people with Non-muscle-invasive Bladder Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-muscle-invasive Bladder Cancer
- What is being tested?
- Standard infusion chemotherapy and BL - 5 ala PDT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Dalin He
Xi'an, Shaanxi, 710061
Dalin He, Dr., 13991288221, hedl@mail.xjtu.edu.cn
Kaijie Wu, Dr., 15389299128, kaijie_wu@163.com
About this study
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
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.
Read the 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:
- Overall Study Design and Plan: a multicenter prospective randomized controlled clinical study;
- Research steps: clinical recruitment, random enrollment, surgical treatment, regular postoperative preventive adjuvant intervention treatment + follow-up observation, and statistical analysis.
- 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).
- 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.
- 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.
- 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.
- Evaluation indicators:
Main Outcome: Tumor recurrence rate 1 year after surgery Secondary Outcome: Observe postoperative complications (focus on side effects beyond standard perfusion therapy)
- Conditions
- Non-muscle-invasive Bladder Cancer
- Being tested
- Standard infusion chemotherapy, BL - 5 ala PDT
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard infusion chemotherapyDrug
Also called Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)
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
BL - 5 ala PDTProcedure or surgery
Also called Blue laser-5ala Photodynamic therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard infusion chemotherapy; Procedure: BL - 5 ala PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
postoperative complications were evaluated by regular urine routine, urinary B-ultrasound and cystoscopy
Measured: from date of randomization until the date of first documented postoperative complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start13 Sep 2022 (estimated)
- Primary completion13 Sep 2022 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dalin He, Dr., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547516
- Sponsor's protocol ID
- 2021ZDLSF02-16
- Acronym
- BL-PDT-RCT
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31443960Messing 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.
PubMed 29801011Agostinis 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.
PubMed 21617154Railkar 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.
PubMed 30145112Kushibiki 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.
PubMed 23390956Ericson 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.
PubMed 12627275
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05547516
- Acronym / sponsor ID
- BL-PDT-RCT / 2021ZDLSF02-16
- Conditions
- Non-muscle-invasive Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (estimated)
- Primary completion
- 13 Sep 2022 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Overall Study Design and Plan: a multicenter prospective randomized controlled clinical study;
- Research steps: clinical recruitment, random enrollment, surgical treatment, regular postoperative preventive adjuvant intervention treatment + follow-up observation, and statistical analysis.
- 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).
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.) | Active comparator | Drug: Standard infusion chemotherapyStandard 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. |
| BL-5ALA-PDT | Active comparator | Drug: Standard infusion chemotherapy, Procedure: BL - 5 ala PDTBl-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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard infusion chemotherapyAlso: Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.)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 | Drug | BL-5ALA-PDT, Standard infusion chemotherapy (including gemcitabine, mitomycin, Epirubicin, etc.) |
| BL - 5 ala PDTAlso: Blue laser-5ala Photodynamic therapyBL - 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. | Procedure or surgery | BL-5ALA-PDT |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 31443960Babjuk 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.
- Background: PubMed 29801011Messing 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.
- Background: PubMed 21617154Agostinis 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.
- Background: PubMed 30145112Railkar 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.
- Background: PubMed 23390956Kushibiki 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.
- Background: PubMed 12627275Ericson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalin He, Dr. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard infusion chemotherapy and BL - 5 ala PDT in people with Non-muscle-invasive Bladder Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalin He, Dr. (13991288221, hedl@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence rate 1 year after surgery (time frame: from date of randomization until the date of first documented Tumor recurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547516, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.