JPRN-jRCTs031220689
Recruiting
Phase 2
A prospective study to investigate the effect of CBM558 combined with pembrolizumab on gut microbiota and prognosis in patients with advanced urothelial carcinoma.
Taguchi Satoru0 sites30 target enrollmentMarch 9, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Taguchi Satoru
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) With unresectable (recurrent, locally advanced, or metastatic) urothelial cancer (bladder, ureters, and urethra cancer)
- •(2\) With cancer progression after chemotherapy, intolerance to chemotherapy or ineligible for chemotherapy
- •(3\) With lesion which is measurable based on RECIST 1\.1
- •(4\) Scheduled to take pembrolizumab
- •(5\) Aged 18 years and above at the time of informed consent
- •(6\) Male or female
- •(7\) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation
Exclusion Criteria
- •(1\) With a history of allergy to pembrolizumab or components of butyrate\-producing probiotics
- •(2\) Taking butyrate\-producing probiotics and unable to have washout period of above 5 days prior to experimental treatment
- •(3\) Pregnant or possible pregnant
- •(4\) Lactating female
- •(5\) Judged as ineligible by clinical investigators
Outcomes
Primary Outcomes
Not specified
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