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Study on the key intestinal microflora affecting the efficacy of Anti-Programmed Death 1 /L1 in Chinese cancer patients

Study on the key intestinal microflora affecting the efficacy of Anti-Programmed Death 1 /L1 in Chinese cancer patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030572
Enrollment
Unknown
Registered
2020-03-07
Start date
2020-03-02
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

case series:N/A

Sponsors

Cancer center of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. To be aged 18 Years old or oldder; 2. Patients receive treatment containing PD-1 / PD-L1; 3. With diagnosis of urothelial cell carcinoma by histology or cytology(pathologist need confirm that the transitional carcinoma is the main part of a mixed type of cancer ); stage: locally advanced and inoperable (T4b and anyN,or anyT andN2-3),M1; primary site:bladder,urinary tract, renal pelvis, urethra; 4. Patients with at least one measurable target lesion according to recist1.1; 5. ECOG performance status <= 2; 6. Life expectance longer than 3 months; 7. Subjects volunteerly participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. With active infection occured 2 weeks before enrollment; 2. Patients with Crohn's disease,ulcerative colitis,intestinal tuberculosis and chronic diarrhea; 3. With long-term (longer than 1 month) oral gatrointestinal probiotic drugs; 4. Patients with autoimmune diseases or who have undergone transplantation; 5. Pregnant or lactating woman; 6. With other active cancers; 7. With history of severe organ diseases,such as heart, lung, liver.

Design outcomes

Primary

MeasureTime frame
Composition of Microorganisms in stool;

Secondary

MeasureTime frame
Relationship between gut microbiota and immunotherapy;

Countries

China

Contacts

Public ContactYanxia Shi

Cancer center of Sun Yat-Sen University

Shiyx@sysucc.org.cn+86 13609058827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026