Non-Muscle Invasive Bladder CancerPhase 3NCT06241755
Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A Phase 3 study testing BCG for Therapeutic Use in people with Non-Muscle Invasive Bladder Cancer, run by Chengdu CoenBiotech Co., Ltd at 1 site in China.
Trial summary
A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk non-muscle invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer
- What is being tested?
- BCG for Therapeutic Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2023to 3 Sep 2026
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female patients aged ≥18 year and ≤75 year
- 2. According to the stipulations of Guidelines on Diagnosing \& Treating Bladder Cancer (Edition 2022) as promulgated by National Health Commission, an initial definite diagnosis of medium/high-risk non-muscle invasive urothelial bladder cancer (T1/Ta/Tis) as confirmed by histological examination and requiring an adjuvant therapy of BCG bladder instillation；
- 3. After a thorough TURBt, all tumors should be grossly invisible. Patients requiring a second procedure are also eligible for inclusion. Those fulfilling the requirements of a second procedure may do so. Patients fulfilling the requirements of a second procedure shall meet the following criteria:
- Criteria of a second TURBt: 1) Initial TURBt is insufficient; 2) No muscular specimen during an initial TURBt; 3) Stage T1 tumor; 4) G3 (advanced grade) tumor, except for simple in situ tumor;
- A second TURBt is recommended within Weeks 2-6 after an initial procedure. It is optimal at Week 4. After TURBt until BCG bladder instillation, no other instillations are allowed except for 1st/2nd immediate instillation chemotherapeutic agents. For the last TURBt, only epirubicin is reserved for immediate instillation chemotherapy;
- Subjects undergoing a second TURBt and starting BCG therapy at Weeks 2-4 after a second procedure;
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- Based upon the first/second result of histopathology examination, comprehensively evaluating whether or not a certain patient is eligible for inclusion.
- 4. A previous history of never receiving any therapy of BCG bladder instillation;
- 5. ECOG score: 0-2 points;
- 6. Clinical laboratory tests fulfilling the following features:
- Blood routine: Within Day 14 prior to randomization, never using any hematopoietic growth factor or blood transfusion, including absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5×109/L; platelet ≥100000/mm3 or 100×109/L; hemoglobin ≥9 g/dL.
- Liver function: total serum bilirubin ≤1.5× upper limit of normal (ULN); for subjects with Gilbert syndrome total serum bilirubin <3×ULN ;AST/ALT ≤2.5×ULN.
- Renal function: defined as estimated creatinine clearance ≥50 mL/min according to the formula of Cockcroft-Gault;
- Blood coagulation function: APTT ≤ 1.5×ULN and INR ≤1.5×ULN.
- 7. Capable of understanding the procedures and methods of clinical study and participating voluntarily after offering thorough informed consents.
Who cannot join
- 1. Current users of immune suppressants, hormones or radiotherapy and potentially causing systemic BCG-related disease responses (patients requiring an injection of matching hormones after thyroidectomy or adrenalectomy are also eligible for inclusion);
- 2. Allergic to BCG or its analogues;
- 3. Presence of active TB lesions, currently receiving an anti-TB therapy or taking any anti-TB regimen within Month 6 prior to screening;
- 4. Known or suspected intraoperative bladder perforation;
- 5. Presence of severe gross hematuria pre-dosing as judged by investigators and with a suspicion of non-healing surgical wound;
- 6. Presence of concurrent cystitis with such signs of cystic irritation as urinary frequency/urgency/pain as judged by investigators or previously receiving therapies of other bladder instillation drugs and irritating bladder signs severe enough to interfere with study evaluations;
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- 7. Individuals with a previous history of such severe adverse events as BCG sepsis or systemic infections;
- 8. Complete cystic urinary incontinence is defined as using six and more pads with 24h;
- 9. Concurrently with other urogenital system tumors or other malignant solid organ tumors;
- 10. Individuals with a previous history of severe cerebrocardiovascular, pulmonary, hepatic and renal diseases or hypertension and diabetes mellitus clinically uncontrollable as judged by investigators;
- 11. Individuals with an evidence of focal advanced or metastatic muscular infiltration urothelial cancer or concurrent extra-cystic non-muscle invasive urothelial transition cell cancer;
- 12. Receiving chemotherapy, radiotherapy or immunotherapy within Week 4 prior to an initial dose (except for immediate postoperative intravesical chemotherapy);
- 13. Pregnant or lactating women;
- 14. Individuals failing to adopt effective birth control measures during study until Month 6 after the last dose;
- 15. Participating in a clinical study of another drug within Month 3 prior to screening;
- 16. Known dependents of opioids or alcohol;
- 17. Any of the following items: Positive antibodies of (HIV, treponema pallidum and acute/chronic active hepatitis B (HBsAg); copy number of HBV-DNA in peripheral blood ≥103/mL; HCV antibody positive with copy number of HCV ≥103 /mL;
- 18. Individuals with mental retardations or poor compliance;
- 19. Any circumstance potentially boosting subject risks or interfering with study implementations as judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510120
Liushan Qu, 020-81332587, sysyxllwyh@163.com
Jian Huang, PhD
About this study
Official title: Phase III Multi-center Randomized, Double-blind and Positive-controlled Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk non-muscle invasive bladder cancer (NMIBC).
Read the detailed description
Instillation of BCG for Therapeutic Use（BCG） into the urinary bladder (intravesical administration) improves rates of tumor recurrence and progression after adequate transurethral resection of bladder (TURBt) of moderate to high risk, non-muscle-invasive bladder cancer (NMIBC).
To determine the efficacy and safety of BCG as an adjuvant therapy method in patients with NMIBC., we conduct a randomized, double-blinded, positive controlled phase 3 clinical trial. The target population is adults with moderate to high risk NMIBC (Ta ，T1 or tis) suitable for intravesical BCG treatment. Key eligibility criteria include prior transurethral resection of all visible tumor, adequate organ function, and ECOG performance status 0-2. 412 Subjects will be administrated with 120mg Intravesical BCG. The treatment includes Induction perfusion period (weekly x 6), followed by maintenance perfusion period (Q2W x 3 times ,then once monthly). totaled with 19 times BCG perfusion, and lasting until 1 year after surgery. The primary endpoint is 1-year recurrence-free survival rate.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- BCG for Therapeutic Use
- Keywords
- Non-Muscle Invasive Bladder Cancer, Bladder Cancer
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG for Therapeutic UseDrug
Also called BCG
Specification: 60 mg (6.0×10^7 CFU)/vial, each vial contains BCG 60 mg and each mg BCG shall have a count of live bacteria not less than 1.0×10^6 CFU.
Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h.
BCG for Therapeutic UseDrug
Also called BCG
Specification: 60 mg/vial with a count of live BCG bacteria not less than 1.0×10^6 CFU/mg.
Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h.
| Study group | Role | What they receive |
|---|---|---|
| Medium-risk non-muscle invasive bladder cancer (NMIBC) | Experimental | Induction phase: Once weekly instillation for six consecutive times; Maintenance phase: Once every two weeks (Q2W) for three consecutive times and then once every four weeks (Q4W) for a total of 19 times. Receives: Drug: BCG for Therapeutic Use |
| High-risk non-muscle invasive bladder cancer (NMIBC) | Experimental | Induction phase: Once weekly instillation for six consecutive times; Maintenance phase: Once every two weeks (Q2W) for three consecutive times and then once every four weeks (Q4W) for a total of 19 times. Receives: Drug: BCG for Therapeutic Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence-free survival (1-year RFS%):
Evaluating the percentage of subjects staying free from recurrence or mortality from randomized to Year 1 (first occurring as a priority)
Measured: 1 year
Secondary outcomes (3)
2-year recurrence-free survival (2-year RFS%)
Measured: 2 year
1-year progression-free survival (1-year PFS%)
Measured: 1 year
2-year progression-free survival (2-year PFS%)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start28 Dec 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion3 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu CoenBiotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241755
- Sponsor's protocol ID
- KN-BCG-III
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multi-center Randomized, Double-blind and Positive-controlled Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT06241755
- Acronym / sponsor ID
- KN-BCG-III
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Keywords
- Non-Muscle Invasive Bladder Cancer, Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Chengdu CoenBiotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 3 Sep 2026 (estimated)
- First posted
- 5 Feb 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.
A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk non-muscle invasive bladder cancer (NMIBC).
Detailed description
Instillation of BCG for Therapeutic Use（BCG） into the urinary bladder (intravesical administration) improves rates of tumor recurrence and progression after adequate transurethral resection of bladder (TURBt) of moderate to high risk, non-muscle-invasive bladder cancer (NMIBC).
To determine the efficacy and safety of BCG as an adjuvant therapy method in patients with NMIBC., we conduct a randomized, double-blinded, positive controlled phase 3 clinical trial. The target population is adults with moderate to high risk NMIBC (Ta ，T1 or tis) suitable for intravesical BCG treatment. Key eligibility criteria include prior transurethral resection of all visible tumor, adequate organ function, and ECOG performance status 0-2. 412 Subjects will be administrated with 120mg Intravesical BCG. The treatment includes Induction perfusion period (weekly x 6), followed by maintenance perfusion period (Q2W x 3 times ,then once monthly). totaled with 19 times BCG perfusion, and lasting until 1 year after surgery. The primary endpoint is 1-year recurrence-free survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium-risk non-muscle invasive bladder cancer (NMIBC) | Experimental | Drug: BCG for Therapeutic UseInduction phase: Once weekly instillation for six consecutive times; Maintenance phase: Once every two weeks (Q2W) for three consecutive times and then once every four weeks (Q4W) for a total of 19 times. |
| High-risk non-muscle invasive bladder cancer (NMIBC) | Experimental | Drug: BCG for Therapeutic UseInduction phase: Once weekly instillation for six consecutive times; Maintenance phase: Once every two weeks (Q2W) for three consecutive times and then once every four weeks (Q4W) for a total of 19 times. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Male or female patients aged ≥18 year and ≤75 year
- 2. According to the stipulations of Guidelines on Diagnosing \& Treating Bladder Cancer (Edition 2022) as promulgated by National Health Commission, an initial definite diagnosis of medium/high-risk non-muscle invasive urothelial bladder cancer (T1/Ta/Tis) as confirmed by histological examination and requiring an adjuvant therapy of BCG bladder instillation；
- 3. After a thorough TURBt, all tumors should be grossly invisible. Patients requiring a second procedure are also eligible for inclusion. Those fulfilling the requirements of a second procedure may do so. Patients fulfilling the requirements of a second procedure shall meet the following criteria:
- 4. A previous history of never receiving any therapy of BCG bladder instillation;
- 5. ECOG score: 0-2 points;
Key exclusion criteria (19 listed)
- 1. Current users of immune suppressants, hormones or radiotherapy and potentially causing systemic BCG-related disease responses (patients requiring an injection of matching hormones after thyroidectomy or adrenalectomy are also eligible for inclusion);
- 2. Allergic to BCG or its analogues;
- 3. Presence of active TB lesions, currently receiving an anti-TB therapy or taking any anti-TB regimen within Month 6 prior to screening;
- 4. Known or suspected intraoperative bladder perforation;
- 5. Presence of severe gross hematuria pre-dosing as judged by investigators and with a suspicion of non-healing surgical wound;
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 |
|---|---|---|
| BCG for Therapeutic UseAlso: BCGSpecification: 60 mg (6.0×10^7 CFU)/vial, each vial contains BCG 60 mg and each mg BCG shall have a count of live bacteria not less than 1.0×10^6 CFU. Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h. | Drug | High-risk non-muscle invasive bladder cancer (NMIBC), Medium-risk non-muscle invasive bladder cancer (NMIBC) |
| BCG for Therapeutic UseAlso: BCGSpecification: 60 mg/vial with a count of live BCG bacteria not less than 1.0×10^6 CFU/mg. Usage \& dosage: Dissolving two vials (120 mg) into 40-50 mL normal saline and shaking thoroughly. Following the procedures of surgical cauterization, inserting a Foley tube into cystic cavity and instilling diluted drug solution. After instillation, constantly changing body positions of a patient, such as left/right recumbent and supine/prostrate. Each position is maintained for around 30 min. Self-discharging drug solution after 2h. | Drug | High-risk non-muscle invasive bladder cancer (NMIBC), Medium-risk non-muscle invasive bladder cancer (NMIBC) |
Primary outcome
1-year recurrence-free survival (1-year RFS%):
Time frame: 1 year
Evaluating the percentage of subjects staying free from recurrence or mortality from randomized to Year 1 (first occurring as a priority)
3 secondary outcomes
2-year recurrence-free survival (2-year RFS%)
Time frame: 2 year
1-year progression-free survival (1-year PFS%)
Time frame: 1 year
2-year progression-free survival (2-year PFS%)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 BCG for Therapeutic Use in people with Non-Muscle Invasive Bladder Cancer, run by Chengdu CoenBiotech Co., Ltd 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 15 inclusion and 19 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 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Huang, PhD (13600054833, hjgcp2017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence-free survival (1-year RFS%): (time frame: 1 year). 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 5 Feb 2024.