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
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age≥ 18 years old, male or female;

• 2\. According to the Guidelines for the Diagnosis and Treatment of Bladder Cancer (2022 Edition), the initial histological diagnosis of intermediate- and high-risk non-muscle-invasive urothelial carcinoma of the bladder (T1, Ta or Tis) and the need for BCG bladder infusion adjuvant therapy is evaluated;

• 3\. Patients undergoing transurethral bladder tumor resection need to meet the requirements of all tumors to have no visible tumors after surgery. This study can also enroll patients who need a second electroresection, subjects who meet the secondary electroresection criteria are recommended to undergo secondary electroresection and should be included in the study after comprehensive evaluation based on the two pathological results (BCG perfusion for treatment should be carried out within 2\

∙ 12 weeks after surgery, cystoscopy should be added more than 4 weeks after surgery to ensure that there is no visible tumor after surgery, and the subjects who underwent secondary resection should be calculated based on the postoperative time of the second electroresection); Note: The criteria for the second resection: (1) the first TURBt is insufficient; (2) the first electrosection of non-myometrial tissue specimens; (3) T1 tumors; (4) High-grade (G3) tumors, except for carcinoma in situ. The second resection is recommended to be performed within 2-6 weeks after the first resection, and no other perfusion therapy is allowed except for the bladder infusion chemotherapy drugs immediately after the first and second resection;

• 4\. Eastern Cooperative Oncology Group (ECOG) score (see Appendix 1 for details): 0\

∙ 2 points;

• 5\. At screening, clinical laboratory tests meet the following characteristics:

‣ Blood routine: no use of hematopoietic growth factors or blood transfusion support within 14 days before randomization, including: absolute neutrophil count (ANC) ≥1500/mm\^3 or ≥1.5×10\^9/L; Platelets≥ 100000/mm\^3 or 100×10\^9/L; Hemoglobin ≥ 9 g/dL.

⁃ Liver function: total bilirubin ≤ 1.5× upper limit of normal range (ULN), subjects with Gilbert's syndrome require total bilirubin \<3×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN.

⁃ Renal function: defined as creatinine clearance estimated according to the Cockcroft Gault formula (Appendix 2) ≥ 30mL/min;

⁃ Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, and the international normalized ratio (INR) ≤ 1.5×ULN.

• 6\. Voluntarily participate in this trial, with full informed consent and signed written informed consent.

Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Beijing Chaoyang Hospital Affiliated to Capital Medical University
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Jilin Provincial People's Hospital
NOT_YET_RECRUITING
Changchun
Hunan Provincial Cancer Hospital
RECRUITING
Changsha
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Army Medical University
NOT_YET_RECRUITING
Chongqing
Union Hospital Affiliated to Fujian Medical University
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Hospital
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Cancer Hospital Affiliated to Harbin Medical University
NOT_YET_RECRUITING
Haerbin
The Second Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of USTC
NOT_YET_RECRUITING
Hefei
People's Hospital of Inner Mongolia Autonomous Region
NOT_YET_RECRUITING
Hohhot
Qilu Hospital of Shandong University
RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Drum Tower Hospital Affiliated to Nanjing University School of Medicine
NOT_YET_RECRUITING
Nanjing
Jiangsu Provincial Cancer Hospital
NOT_YET_RECRUITING
Nanjing
Cancer Hospital Affiliated to Guangxi Medical University
RECRUITING
Nanning
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Huadong Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Shanghai Changhai Hospital
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xian
Xingtai People's Hospital
RECRUITING
Xingtai
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Wei Ding Ye, Doctor
dwyeli@163.com
13701663571
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 438
Treatments
Experimental: Experimental group
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.
Active_comparator: Control group
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.
Related Therapeutic Areas
Sponsors
Leads: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

This content was sourced from clinicaltrials.gov

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