Actively Recruiting
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Led by Lepu Biopharma Co., Ltd. · Updated on 2026-04-23
16
Participants Needed
14
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
CONDITIONS
Official Title
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older at the time of informed consent.
- Have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without Ta/T1 papillary disease.
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have all Ta and/or T1 disease resected and all CIS resected or fulgurated as feasible before study treatment.
- Demonstrate adequate organ function.
- Be willing to comply with required cystoscopies, urine cytology, urograms, biopsies, and other procedures during the study.
- Be ineligible for or refuse radical cystectomy as assessed by the Investigator.
You will not qualify if you...
- Have current or past muscle invasive (T2 or higher), locally advanced (T3/T4, any N), or metastatic bladder cancer.
- History of urothelial carcinoma in the upper genitourinary tract or prostatic urethra, including urethral CIS, within 24 months before enrollment.
- Have received systemic anti-cancer therapy, including investigational agents.
- Have had prior systemic treatment (except checkpoint inhibitors), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
- Have had myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass graft, stroke, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure within 6 months before study treatment.
- Cannot tolerate study-related biopsies, intravesical (IVE) administration, or a 1-hour bladder hold of Cretostimogene.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Peking University First Hospital (First Clinical Medical School of Peking University)
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
6
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
7
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
8
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
9
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
11
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
12
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
13
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
P
Program Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here