Urinary Bladder NeoplasmsPhase 3NCT06441110
Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
A Phase 3 study testing Tislelizumab in Combination with Bacillus Calmette-Guérin in people with Urinary Bladder Neoplasms and BCG Vaccine, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active
- What is being tested?
- Tislelizumab in Combination with Bacillus Calmette-Guérin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the trial with signed informed consent;
- Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);
- Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
- Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.
Who cannot join
- Any of the following conditions:
- Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;
- Concurrent urogenital system tumors or tumors in other organs;
- Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
- Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);
- Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);
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- Known or suspected intraoperative bladder perforation;
- Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;
- Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;
- Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;
- Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;
- Participation in other drug clinical trials within 3 months before enrollment;
- Known or suspected opioid or alcohol dependence;
- Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian, 350000
Jiabing Zheng, +8613799422519, xhyykjk@163.com
About this study
Official title: Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.
- Conditions
- Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active, Multicenter Study, Treatment Outcome, Neoplasm Recurrence, Local
- Being tested
- Tislelizumab in Combination with Bacillus Calmette-Guérin
- Medical subject headings
- Urinary Bladder Neoplasms, Motor Activity, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab in Combination with Bacillus Calmette-GuérinDrug
Postoperative immediate instillation of epirubicin (50mg) is administered. Postoperatively, 200mg of tislelizumab injection is given intravenously every 3 weeks, with each 21-day period constituting one cycle. The medication is administered on day 1 of each cycle, continuing for one year. Eligible patients for the single-arm group (N = 76) begin BCG instillation after 2 weeks, with a dosage of 120mg per instillation, totaling 19 instillations: this starts with a 6-week induction phase of weekly BCG instillations, followed by BCG instillations every 2 weeks for three consecutive times; thereafter, maintenance instillation therapy commences, involving monthly BCG instillations for a total of ten times.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Instillation Therapy Group | Experimental | Tislelizumab in Combination with Bacillus Calmette-Guérin for the Treatment of Intermediate and High-Risk NMIBC Group Receives: Drug: Tislelizumab in Combination with Bacillus Calmette-Guérin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival(RFS)
The time from postoperative cystoscopic examination to the first documented recurrence of bladder tumor.
Measured: From date of postoperative cystoscopic examination to the first documented recurrence of bladder tumor,assessed up to 60 months.
Secondary outcomes (3)
Progression-Free Survival(PFS)
The time recorded from postoperative cystoscopic and pathological examinations to the first progression of bladder tumor, defined in this trial as the occurrence of muscle-invasive growth in NMIBC (Non-Muscle Invasive Bladder Cancer) patients.
Measured: From date of postoperative cystoscopic and pathological examinations to the first progression of bladder tumor, assessed up to 60 months.
Overall survival
The duration from post-surgery to the time of death due to any cause. For participants who are lost to follow-up prior to death, the time of their last follow-up is typically considered as the time of death for calculation purposes.
Measured: From date of post-surgery to the time of death due to any cause,assessed up to 60 months
Adverse event（AS)
An adverse event (AE) is defined according to the toxicity grading standards set by the National Cancer Institute of the United States. This includes a spectrum of adverse reactions associated with antineoplastic therapy. Specific grading of adverse reactions refers to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) developed by the National Cancer Institute (NCI).
Measured: From date of post-surgery to the time of death due to any cause,assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenlin Chen, Principal investigator, Department of Urology, Fujian Union Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441110
- Sponsor's protocol ID
- 2023XHYG0045-02
- Status last verified
- Apr 2024
- First submitted
- 14 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT06441110
- Acronym / sponsor ID
- 2023XHYG0045-02
- Conditions
- Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active, Multicenter Study, Treatment Outcome, Neoplasm Recurrence, Local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2035 (estimated)
- First posted
- 4 Jun 2024 (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.
Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Instillation Therapy Group | Experimental | Drug: Tislelizumab in Combination with Bacillus Calmette-GuérinTislelizumab in Combination with Bacillus Calmette-Guérin for the Treatment of Intermediate and High-Risk NMIBC Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary participation in the trial with signed informed consent;
- Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);
- Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
- Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.
Key exclusion criteria (14 listed)
- Any of the following conditions:
- Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;
- Concurrent urogenital system tumors or tumors in other organs;
- Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
- Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);
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 |
|---|---|---|
| Tislelizumab in Combination with Bacillus Calmette-GuérinPostoperative immediate instillation of epirubicin (50mg) is administered. Postoperatively, 200mg of tislelizumab injection is given intravenously every 3 weeks, with each 21-day period constituting one cycle. The medication is administered on day 1 of each cycle, continuing for one year. Eligible patients for the single-arm group (N = 76) begin BCG instillation after 2 weeks, with a dosage of 120mg per instillation, totaling 19 instillations: this starts with a 6-week induction phase of weekly BCG instillations, followed by BCG instillations every 2 weeks for three consecutive times; thereafter, maintenance instillation therapy commences, involving monthly BCG instillations for a total of ten times. | Drug | Postoperative Instillation Therapy Group |
Primary outcome
Relapse-Free Survival(RFS)
Time frame: From date of postoperative cystoscopic examination to the first documented recurrence of bladder tumor,assessed up to 60 months.
The time from postoperative cystoscopic examination to the first documented recurrence of bladder tumor.
3 secondary outcomes
Progression-Free Survival(PFS)
Time frame: From date of postoperative cystoscopic and pathological examinations to the first progression of bladder tumor, assessed up to 60 months.
Overall survival
Time frame: From date of post-surgery to the time of death due to any cause,assessed up to 60 months
Adverse event（AS)
Time frame: From date of post-surgery to the time of death due to any cause,assessed up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
Zhenlin Chen principal investigator
Department of Urology, Fujian Union Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab in Combination with Bacillus Calmette-Guérin in people with Urinary Bladder Neoplasms and BCG Vaccine, run by Fujian Medical University Union Hospital 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 Jun 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiabing Zheng (+8613799422519, xhyykjk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival(RFS) (time frame: From date of postoperative cystoscopic examination to the first documented recurrence of bladder tumor,assessed up to 60 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.