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)

NCT06241755 | Recruiting Phase 3

• 1 other identifier: KN-BCG-III
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non-Muscle Invasive Bladder Cancer

Keywords

Non-Muscle Invasive Bladder Cancer; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Secondary Outcomes (3)

• 2-year recurrence-free survival (2-year RFS%)

  2 year

• 1-year progression-free survival (1-year PFS%)

  1 year

• 2-year progression-free survival (2-year PFS%)

  2 year

Study Arms (2)

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.

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.

Drug: BCG for Therapeutic Use

Interventions

BCG for Therapeutic Use DRUG

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.

Also known as: BCG

High-risk non-muscle invasive bladder cancer (NMIBC); Medium-risk non-muscle invasive bladder cancer (NMIBC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female patients aged ≥18 year and ≤75 year
• \. 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；
• 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;
• \. A previous history of never receiving any therapy of BCG bladder instillation;
• \. ECOG score: 0-2 points;
• \. 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.
• \. Capable of understanding the procedures and methods of clinical study and participating voluntarily after offering thorough informed consents.

You may not qualify if:

• \. Allergic to BCG or its analogues;
• \. Presence of active TB lesions, currently receiving an anti-TB therapy or taking any anti-TB regimen within Month 6 prior to screening;
• \. Known or suspected intraoperative bladder perforation;
• \. Presence of severe gross hematuria pre-dosing as judged by investigators and with a suspicion of non-healing surgical wound;
• \. 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;
• \. Individuals with a previous history of such severe adverse events as BCG sepsis or systemic infections;
• \. Complete cystic urinary incontinence is defined as using six and more pads with 24h;
• \. Concurrently with other urogenital system tumors or other malignant solid organ tumors;
• \. Individuals with a previous history of severe cerebrocardiovascular, pulmonary, hepatic and renal diseases or hypertension and diabetes mellitus clinically uncontrollable as judged by investigators;
• \. Individuals with an evidence of focal advanced or metastatic muscular infiltration urothelial cancer or concurrent extra-cystic non-muscle invasive urothelial transition cell cancer;
• \. Receiving chemotherapy, radiotherapy or immunotherapy within Week 4 prior to an initial dose (except for immediate postoperative intravesical chemotherapy);
• \. Pregnant or lactating women;
• \. Individuals failing to adopt effective birth control measures during study until Month 6 after the last dose;
• \. Participating in a clinical study of another drug within Month 3 prior to screening;
• \. Known dependents of opioids or alcohol;

Sponsors & Collaborators

• Chengdu CoenBiotech Co., Ltd: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Interventions

Therapeutic Uses

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Jian Huang, PhD

CONTACT

13600054833; hjgcp2017@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: December 28, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 3, 2026
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)