Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase I Clinical Study to Investigate the Safety and Tolerance of Therapeutic Bacillus Calmette-Guerin( BCG) in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
Study ID: NCT06350838
Conditions
Interventions
Study Description
Brief 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)
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hunan Cancer Hospital, Changsha, Hunan, China
Contact Details
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