AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

RecruitingPhase 2Ages 18 Years - anyAllLepu Biopharma Co., Ltd.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: In order to be eligible for participation in this trial, the patient must: 1. Be โ‰ฅ18 years of age on day of signing informed consent. \- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease. 2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment. 4. Demonstrate adequate organ function. 5. Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial. 6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment. Exclusion Criteria: 1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer. 2. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment. 3. Has received systemic anti-cancer therapy, including investigational agents. 4. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies. 5. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure. 6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.
๐Ÿ’Š

What it tests

  • Cretostimogene Grenadenorepvec
  • n-dodecyl-B-D-maltoside
๐Ÿ“

Where

14 sites
Peking University First Hospital (First Clinical Medical School of Peking University)
Beijing, China
Chongqing University Cancer Hospital
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Hunan Cancer Hospital
Changsha, China
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
The First Hospital of China Medical University
Shenyang, China
Qilu Hospital of Shandong University
Jinan, China

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy