A Phase 3 interventional study of BCG for Therapeutic Use and BCG for Therapeutic Use ( BI SAI JI ) in BCG, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 3, Interventional, and Treatment
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).
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's enrollment of 439 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
5. At screening, clinical laboratory tests meet the following characteristics:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Common name: BCG for Therapeutic Use Specification: 60mg/bottle. Each bottle contains 60mg of BCG, and the number of viable bacteria per 1mg BCG should not be less than 1.0×10\^6CFU. Expiration date: 24 months. Production unit: Anhui Zhifeilong Kema Biopharmaceutical Co., Ltd.
Drug: BCG for Therapeutic Use
Common name: BCG for Therapeutic Use ( BI SAI JI ) Specification: 60mg (6.0×10\^7CFU)/bottle. Each bottle contains 60mg of BCG, and the number of viable bacteria per 1mg BCG should not be less than 1.0×10\^6CFU. Expiration date: 18 months. Production unit: Chengdu Institute of Biological Products Co., Ltd.
Drug: BCG for Therapeutic Use ( BI SAI JI )
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.
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.
1-year RFS%
To assess the proportion of participants who were free of recurrence or death (whichever occurs first) from randomisation up to 1 year.
Time frame: Up to 1 year after randomization
Safety endpoints
Incidence of all AEs
Time frame: 30 days after the last dose
Safety endpoints
Incidence of all SAEs
Time frame: 30 days after the last dose
Safety endpoints
Any clinically significant abnormalities of vital signs during the trial
Time frame: 30 days after the last dose
Safety endpoints
Any clinically significant abnormalities found in the physical examination during the trial
Time frame: 30 days after the last dose
Safety endpoints
Any clinically significant abnormalities in laboratory tests during the trial
Time frame: 30 days after the last dose
Safety endpoints
Any clinically significant abnormalities in the electrocardiogram (ECG) examination during the trial
Time frame: 30 days after the last dose
2-years RFS%
To assess the proportion of participants who were free of recurrence or death (whichever occurs first) from randomization up to 2 years.
Time frame: Up to 2 years after randomization
1-year PFS%
To assess the proportion of participants with tumor progression or death from randomization up to 1 year.
Time frame: Up to 1 year after randomization
2-years PFS%
To assess the proportion of participants with tumour progression or death from randomisation up to 2 years.
Time frame: Up to 2 years after randomization
To evaluate the PD characteristics of the therapeutic BCG vaccine for adjuvant therapy after transurethral resection of intermediate- and high-risk NMIBC
Changes in levels of IL-2 in urine
Time frame: The 1st , 6th , 9th and 10th (V10) doses were last excreted before administration, 4 h±1 h, 8 h± 2 h, and 24 h±3 h after administration
To evaluate the PD characteristics of the therapeutic BCG vaccine for adjuvant therapy after transurethral resection of intermediate- and high-risk NMIBC
Changes in levels of IL-6 in urine
Time frame: The 1st , 6th , 9th and 10th (V10) doses were last excreted before administration, 4 h±1 h, 8 h± 2 h, and 24 h±3 h after administration
To evaluate the PD characteristics of the therapeutic BCG vaccine for adjuvant therapy after transurethral resection of intermediate- and high-risk NMIBC
Changes in levels of IL-8 in urine
Time frame: The 1st , 6th , 9th and 10th (V10) doses were last excreted before administration, 4 h±1 h, 8 h± 2 h, and 24 h±3 h after administration
To evaluate the PD characteristics of the therapeutic BCG vaccine for adjuvant therapy after transurethral resection of intermediate- and high-risk NMIBC
Changes in levels of IL-12 in urine
Time frame: The 1st , 6th , 9th and 10th (V10) doses were last excreted before administration, 4 h±1 h, 8 h± 2 h, and 24 h±3 h after administration
To evaluate the PD characteristics of the therapeutic BCG vaccine for adjuvant therapy after transurethral resection of intermediate- and high-risk NMIBC
Changes in levels of IFN-γ in urine
Time frame: The 1st , 6th , 9th and 10th (V10) doses were last excreted before administration, 4 h±1 h, 8 h± 2 h, and 24 h±3 h after administration
To evaluate the PD characteristics of the therapeutic BCG vaccine for adjuvant therapy after transurethral resection of intermediate- and high-risk NMIBC
Changes in levels of TNF in urine
Time frame: The 1st , 6th , 9th and 10th (V10) doses were last excreted before administration, 4 h±1 h, 8 h± 2 h, and 24 h±3 h after administration
Started Apr 2025 (actual). Primary completion is estimated for Apr 2028, 36 months after the start.
Of 39 industry-sponsored phase 3 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 74. This study's planned 36 months is below that.
Counting every sponsor, half of 73 studies reached it within 65 months; a quarter within 40 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: BCG Vaccine
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. →