CompletedNCT06350838Updated Apr 5, 2024

Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)

A Phase 1 interventional study of BCG for Therapeutic Use in Non-muscular Invasive Bladder Cancer, sponsored by Chengdu CoenBiotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by Chengdu CoenBiotech Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 1 year 2 months after the study started (first participant enrolled Nov 2022, registered Jan 2024).

Phase: Phase 1
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 18 Years to 85 Years
Sex: All

Study summary

Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)

Read the detailed description

The purpose of this study was to evaluate the safety and tolerance, pharmacokinetic characteristics, ablative status, and immune response characteristics of the therapeutic BCG in postoperative adjuvant therapy in subjects with moderate and high-risk non-invasive bladder cancer (NMIBC).

The study consisted of three phases: screening period, administration observation period and safety follow-up period. subjects will be treated with 120 mg BCG.

Conditions studied

Non-muscular Invasive Bladder Cancer

Browse trials for

Urinary Bladder Neoplasms 1,616

Keywords

Non-muscular invasive bladder cancer
bladder cancer

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Chengdu CoenBiotech Co., Ltd is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects were ≥18 years old and ≤85 years old, male or female;
Subjects with non-myoinvasive bladder uroepithelial carcinoma initially diagnosed by histology [T1, Ta, or Tis stage (carcinoma in situ)] and assessed as moderate to high-risk non-myoinvasive bladder uroepithelial carcinoma requiring BCG injection adjuvant therapy according to the Guidelines for Bladder Cancer Diagnosis and Treatment (2022 edition); (Subjects considered for secondary resection may be included in the study after completion of secondary resection and pathology results confirm moderate or high risk non-myoinvasive bladder cancer);
ECOG score: 0-2;
Clinical laboratory tests meet the following characteristics:
1. Blood routine: no hematopoietic growth factor or transfusion support was used within 14 days prior to enrollment, including: absolute neutrophil value (ANC) ≥1500/mm3 or ≥1.5×109/L; Platelets ≥100000/mm3 or 100×109/L; Hemoglobin ≥9 g/dL.
2. Liver function: total serum bilirubin ≤1.5× upper limit of normal range (ULN), total serum bilirubin \<3×ULN in subjects with Gilbert syndrome, aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN.
3. Renal function: defined as creatinine clearance ≥45 to 50 mL/min as estimated by the Cockcroft Gault formula.
4. Coagulation function: Activated partial thromboplastin time (APTT) ≤1.5×ULN, International Normalized ratio (INR) ≤1.5×ULN
The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Exclusion criteria

Exclusion Criteria:

Any of the following:
1. Patients who are using immunosuppressive drugs, hormone drugs, or radiation therapy that the investigator has determined to be likely to cause systemic BCG disease reactions (patients who hormone injections for thyroid/adrenal resection may be included);
2. Allergic to BCG vaccine or BCG products;
3. Have active TB changes or are receiving anti-TB therapy;
4. Known or suspected intraoperative perforation of the bladder; e Serious gross hematuria before administration was judged by the investigator, and the surgical wound was suspected to have not healed.
f. The evaluators were judged to be associated with cystitis, or had previously received other bladder perfusion drugs, and were expected to have severe bladder irritation.
f. Patients with a history of severe adverse reactions to BCG (BCG) sepsis or systemic infection; g. Complete bladder incontinence, defined as the use of six or more pads in a 24-hour period; h. Complete bladder incontinence, defined as the use of six or more pads in a 24-hour period;
Combined with other genitourinary tumors or malignancies of other organs;
Accompanied by serious diseases of cardiovascular and cerebrovascular, lung, liver, kidney and other important organs, or severe hypertension or diabetes that researchers judge can not be controlled clinically;
Patients suffering from acute infectious diseases at the time of screening;
Evidence of Myoinvasive locally advanced or metastatic urothelial carcinoma, or extrinsic non-Myoinvasive urothelial metastasized cell carcinoma, as determined by the investigator;
Study participants who had received chemotherapy, radiation therapy, or anti-tumor immunotherapy within 4 weeks prior to treatment (except for immediate postoperative bladder infusion chemotherapy);
Pregnant or lactating women;
Subjects who are unable to use effective contraception during the trial period and within 3 months after the last dose;
Participants who had participated in clinical trials of other therapeutic drugs within 1 month prior to enrollment;
Known opioid or alcohol dependence;
Human immunodeficiency virus (HIV) antibody, syphilis specific antibody positive, acute or chronic active hepatitis B (hepatitis B surface antigen (HBsAg) positive, and peripheral blood hepatitis B copy number ≥103/mL), hepatitis C virus (HCV) antibody positive (HCV copy number ≥10/mL);
Patients with mental disorders or poor compliance as judged by the investigator;
Any conditions that the investigator believes may increase risk to the subject or interfere with the execution of the clinical trial.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
Medium/high-risk non-muscle invasive bladder cancer (NMIBC)
Medium/high-risk NMIBC (Ta, T1 or Tis) suitable for intravesical BCG treatment.Three phases included: screening period (28 days before the first dose), observation period (6 weeks) and safety follow-up period (7 days after the last dose).
Drug: BCG for Therapeutic Use

Interventions

DrugBCG for Therapeutic Use
Take 120 mg BCG for treatment, dissolved in 40 \~ 50 mL normal saline, bladder perfusion through catheter. The injection was performed once a week for 6 consecutive times.
Also known as: BCG

What researchers measure

Primary outcomes

Incidence of Treatment-Emergent Adverse Events(TEAE) and serious Treatment-Emergent Adverse Events;
Probability of AE and SAE after administration.
Time frame: 6 weeks
Effects on clinical laboratory tests index of blood biochemistry, such as the concentration of alanine aminotransferase (ALT).
Probability of abnormal laboratory parameters of blood biochemistry compared with baseline，such as the concentration of alanine aminotransferase (ALT).
Time frame: 6 weeks
Effects on clinical laboratory tests index of blood routine, such as white blood cell count, red blood cell count, platelet count.
Probability of abnormal laboratory parameters of blood routine compared with baseline, such as white blood cell count, red blood cell count, platelet count.
Time frame: 6 weeks
Effects on clinical laboratory tests index of coagulation function, such as activated partial thromboplastin time (APTT).
Probability of abnormal laboratory parameters of coagulation function compared with baseline，such as activated partial thromboplastin time (APTT).
Time frame: 6 weeks
Effects on clinical laboratory tests index of urine routine, such as white urine albumin count, urine red blood cell count.
Probability of abnormal laboratory parameters of urine routine compared with baseline，such as urine albumin count, urine red blood cell count.
Time frame: 6 weeks
Effects on vital signs,such as temperature.
Probability of abnormal laboratory parameters of vital signs compared with baseline，such as temperature(℃).
Time frame: 6 weeks
Effects on P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram.
Probability of abnormal laboratory parameters compared with baseline， including P wave, QRS complex, QT interval and so on by 12-lead electrocardiogram.
Time frame: 6 weeks
Effects on the periodic activity of echocardiography，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure.
Probability of abnormal laboratory parameters of echocardiography compared with baseline，such as the heart wall recorded as the relationship curve between the corresponding activity and time of each structure.
Time frame: 6 weeks
Effects on physical examination, refers to the detection and measurement of the development level of human form, structure and function.
Probability of abnormal laboratory parameters of examination compared with baseline，such as any abnormalities in the skin.
Time frame: 6 weeks

Secondary outcomes

Exposure condition of the test drug in the blood, refer to plasma concentration of the test drug(BCG).
Exposure to the test drug in the blood，detecting the amount and concentration of drug.
Time frame: 6 weeks
Shedding condition of the test drug in urine.
Exposure to the test drug and in urine，detecting the amount and concentration of drug.
Time frame: 6 weeks
To investigate the immune response characteristics of therapeutic BCG in patients with moderate and high- risk non-invasive bladder cancer after surgery.
The amount and concentration levels of IL-2, IL-6, IL-8, IL-12, IFN-γ, and TNF in urine.
Time frame: 6 weeks

Study locations

1 site

Hunan Cancer Hospital
Changsha, Hunan 415000, China

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06350838
Lead sponsor: Chengdu CoenBiotech Co., Ltd
Collaborators: Hunan Cancer Hospital
Responsible party: Sponsor
First posted: Apr 5, 2024
Start date: Nov 11, 2022
Primary completion: Feb 13, 2023
Completion: Feb 13, 2023
Last update: Apr 5, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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