NCT06747455

BCG for Therapeutic Use Phase Ⅲ Clinical Trial

A Randomized, Double-blind, Active-controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of Therapeutic BCG for the Prevention of Postoperative Recurrence of Non-muscle-invasive Bladder Cancer in People Aged 18 Years and Older

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (estimated)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Research topic: A randomized, double-blind, active-controlled, multicenter phase III clinical trial evaluating the efficacy and safety of therapeutic BCG for the prevention of postoperative recurrence of non-muscle-invasive bladder cancer in people aged 18 years and older. The name of the drug: Bacillus Calmette-Guérin for treatment(BCG). Clinical indications: It is used for the treatment of bladder carcinoma in situ and the prevention of recurrence, and for the prevention of recurrence of bladder papilloma after transurethral resection in Ta or T1 stage. This product is not used for papillomas beyond the T1 stage. Study population: Patients aged 18 years and above with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) who have undergone transurethral bladder tumor resection. Objectives: Primary Objectives: To assess the effectiveness of BCG for therapeutic use in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Secondary Purpose: To assess the safety of the therapeutic BCG vaccine in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Other purposes: To assess the pharmacodynamic (PD) profile of BCG for therapeutic use in the adjuvant treatment of intermediate- and high-risk NMIBC after transurethral resection of bladder tumors. Study design: This study adopts a randomized, double-blind, active-controlled, multi-center trial design, including three phases: screening period, treatment period and follow-up period. In this study, 438 subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio, with 219 patients in both the experimental group and the control group, and stratified according to the baseline risk level (high-risk/intermediate-risk) and whether or not to perform urine PD sample collection (yes/no).

Detailed description

Research topic: A randomized, double-blind, active-controlled, multicenter phase III clinical trial evaluating the efficacy and safety of therapeutic BCG for the prevention of postoperative recurrence of non-muscle-invasive bladder cancer in people aged 18 years and older. Study endpoints: Endpoint efficacy: Main efficacy measures: 1-year recurrence-free survival rate (1-year RFS%): To assess the proportion of participants who are relapse-free or die from randomization up to 1 year, whichever occurs first. Secondary efficacy endpoint: 2-year recurrence-free survival rate (2-year RFS%): Assessing the proportion of subjects who have not experienced recurrence or death (whichever occurs first) from randomization until 2 years. 1-year progression-free survival rate (1-year PFS%): Assessing the proportion of subjects experiencing tumor progression or death from randomization until 1 year. The 2-year progression-free survival rate (2-year PFS%) assesses the proportion of subjects experiencing tumor progression or death from the time of randomization until 2 years. Security endpoint: Incidence of all AEs and SAEs; Any clinically significant abnormalities in vital signs or physical examinations during the trial period; Any clinically significant abnormalities found during the trial period laboratory examinations or electrocardiogram examinations. Other destinations: Changes in the levels of interleukin 2 (IL-2), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-12 (IL-12), interferon γ (IFN-γ), and tumor necrosis factor (TNF) in urine excreted at 4 h±1 h, 8 h±, 2 h, and 24 h±3 h after the 1st (V1), 6th (V6), 9th (V9), and 10th (V10) administration. Overall design: This study adopts a randomized, double-blind, positive-controlled, multicenter trial design, including three phases: screening, treatment, and follow-up. A total of 438 subjects will be enrolled in this study, with a 1:1 random allocation to the experimental group and the control group, both consisting of 219 subjects. Stratification will be based on baseline risk level (high risk/medium risk) and whether urine PD samples are collected (yes/no). Selection period: During the first 28 days prior to administration, the subjects will undergo eligibility confirmation for enrollment. Subjects who meet the eligibility criteria will enter the treatment phase and receive the investigational drug infusion. Treatment period (Year 1): The treatment period includes the induction phase, consolidation phase, and maintenance phase. After undergoing transurethral bladder tumor resection, eligible subjects are screened and randomly assigned to the study. Within 2 to 12 weeks after surgery, subjects receive bladder instillation therapy: once a week during the induction phase for a total of 6 times, once every two weeks during the consolidation phase for a total of 3 times, and once every 4 weeks during the maintenance phase for a total of 19 times, continuing until 1 year after surgery. During the first year of the study, subjects undergo imaging examinations every 12 months, urine cytology examinations every 3 months, and cystoscopy. If a subject shows positive results in either cystoscopy or urine cytology, the researcher may decide to perform additional imaging examinations. Early Termination of Treatment Visit: For subjects who discontinue treatment early without completing the first year of infusion therapy in the treatment period and without experiencing tumor recurrence or progression, an Early Termination of Treatment Visit will be conducted within 30 days after the last dose. If subsequent other local or systemic anti-tumor therapies are received, this should be accurately recorded. Follow-up period (Year 2): After completing the first year of infusion therapy in the treatment period, or for subjects who discontinued treatment early without tumor recurrence or progression, or subjects who continue receiving treatment into the second year, follow-up will be conducted during the second year of the study. All subjects meeting the above conditions will undergo imaging examinations every 12 months, and urine cytology examinations and cystoscopy every 3 months, until the subject experiences tumor recurrence or progression, withdraws informed consent, is lost to follow-up, the sponsor terminates the study, or death occurs (whichever occurs first). If a subject has a positive result in either cystoscopy or urine cytology, the investigator may decide to perform additional imaging examinations. This trial plans to conduct the first analysis of the efficacy and safety of the investigational product after all subjects have experienced recurrence or death, or have completed one year of follow-up observation. The first analysis will involve unblinding and statistical analysis performed by a firewalled unblinded team, while the main study team will remain blinded at the individual subject level to continue follow-up of trial subjects. The final unblinding and statistical analysis will be conducted upon completion of the entire trial.

Conditions

• BCG

Interventions

Type	Name	Description
DRUG	BCG for Therapeutic Use	After the subjects after transurethral bladder tumor resection were screened and randomly enrolled, the subjects were given intravesical infusion (experimental drug) within 2\~12 weeks after surgery, and perfused once a week for 6 consecutive times during the induction period; During the intensive phase, perfusion is given once every two weeks, 3 times in a row; During the maintenance period, perfusion was given once every 4 weeks, for a total of 19 perfusions, and the perfusion time continued until 1 year after surgery.
DRUG	BCG for Therapeutic Use ( BI SAI JI )	After the subjects after transurethral bladder tumor resection were screened and randomly enrolled, the subjects were administered intravesical infusion (control drug) within 2\~12 weeks after surgery, and perfused once a week for 6 consecutive times during the induction period; During the intensive phase, perfusion is given once every two weeks, 3 times in a row; During the maintenance period, perfusion was given once every 4 weeks, for a total of 19 perfusions, and the perfusion time continued until 1 year after surgery.

Timeline

• Start date: 2025-04-08
• Primary completion: 2028-10-01
• Completion: 2028-12-31
• First posted: 2024-12-24
• Last updated: 2025-12-23

Locations

1 site across 1 country: China