Skip to content

Gut microbiota intervention influence the efficacy of tumor immunotherapy

Gut microbiota intervention influence the efficacy of tumor immunotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026903
Enrollment
Unknown
Registered
2019-10-26
Start date
2019-11-30
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

cancer

Interventions

1:CAR-T
2:PD-1/PD-L1 inhibitor
3:PD-1/PD-L1 inhibitor
4:immunotherapy
5:immunotherapy + microbial intervention

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Gender is not limited; 3. Lymphoma patients, malignant melanoma or lung cancer patients who meet the CAR-T or PD-1/PD-L1 inhibitor treatment indications, specifically Lymphoma group: relapsed refractory B cell lymphoma, currently unable to perform stem cell transplantation, tumor cell CD19 expression positive; Malignant melanoma group: melanoma that cannot be surgically removed or metastatic; Lung cancer group: metastatic non-small cell lung cancer with disease progression or ineffective after chemotherapy and without EGFR or ALK mutation; 4. The expected lifetime is more than 3 months; 5. ECOG (Eastern Cooperative Oncology Group, ECOG) has a fitness score of 0 to 2; 6. Blood test:HB >= 80g/L, ANC >= 1x10^9/L, PLT>= 50x10^9/L; 7. Patients must be able to sign informed consent and be able to understand the possible risks associated with micro-ecological interventions; 8. Willing to provide stool, blood and tumor biopsy on time.

Exclusion criteria

Exclusion criteria: 1. Patients who have difficulty swallowing or have gastrointestinal obstruction; 2. Patients with autoimmune diseases, or extremely low immunity, or other diseases requiring systemic use of immunosuppressive drugs or hormones; 3. Human immunodeficiency virus (HIV)-positive or active hepatitis B or C infection; 4. Pregnant or lactating women; 5. The investigator has assessed that the study is not conducive to the patient and is not suitable for other situations in which the study was conducted.

Design outcomes

Primary

MeasureTime frame
Evaluation of tumor therapy efficacy based on RECIST1.1;

Secondary

MeasureTime frame
Gut microbiome;Fecal metabolomics;Immune factor;

Countries

China

Contacts

Public ContactLi Ning

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

liningrigsnju@163.com+86 021 66302161

Outcome results

None listed

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