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)
NCT06350838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-04-05
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)
Conditions
- Non-muscular Invasive Bladder Cancer
Interventions
- DRUG
-
BCG for Therapeutic Use
Take 120 mg BCG for treatment, dissolved in 40 \~ 50 mL normal saline, bladder perfusion through catheter. The injection was performed once a week for 6 consecutive times.
Sponsors & Collaborators
-
Hunan Cancer Hospital
collaborator OTHER -
Chengdu CoenBiotech Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-11
- Primary Completion
- 2023-02-13
- Completion
- 2023-02-13
Countries
- China
Study Locations
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