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Clinical Trial 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)


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06350838
Study type Interventional
Source Chengdu CoenBiotech Co., Ltd
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Status Completed
Phase Phase 1
Start date November 11, 2022
Completion date February 13, 2023