Skip to content

Gut microbiota intervention influence the efficacy of tumor immunotherapy (interventional study)

Gut microbiota intervention influence the efficacy of tumor immunotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047044
Enrollment
Unknown
Registered
2021-06-07
Start date
2021-06-06
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

cancer

Interventions

Sponsors

The Tenth People' s Hospital, Medical School of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 16 years old; 2. Gender is not limited; 3. Cancer patients who had received or were receiving PD-1 / PD-L1 inhibitors and were evaluated as SD or PD; 4. The expected survival time is more than 3 months; 5. ECoG (Eastern Cooperative Oncology Group, ECoG) score was 0-2; 6. Blood routine: HB >= 80g / L, ANC >= 1 x 10^9/LPLT >= 50 x 10^9/L 7. Patients must be able to sign informed consent and understand the possible risks of microecological intervention; 8. Willing to provide stool, blood and tumor biopsy on time.

Exclusion criteria

Exclusion criteria: 1. Patients with dysphagia or digestive tract obstruction; 2. Patients with autoimmune diseases or extremely low immunity, or other diseases requiring systemic immunosuppressive drugs or hormone therapy; 3. HIV positive or active hepatitis B or C infection; 4. Pregnant or lactating women; 5. After evaluation, the researchers think that the study is not beneficial to patients, or the patient is not suitable for other situations of the study.

Design outcomes

Primary

MeasureTime frame
Gut microbiome;Immune status;Side effects of Fecal Microbiota Transplantation;

Secondary

MeasureTime frame
Tumor efficacy related indicators;Immune related side effects;

Countries

China

Contacts

Public ContactLi Ning

The Tenth People's Hospital, Medical School of Tongji University

liningrigsnju@163.com+86 2166302161

Outcome results

None listed

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