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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06350838 on ClinicalTrials.gov