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Study on the correlation between intestinal microbiota differential metabolites and the efficacy and gastrointestinal reactions of third-generation EGFR-TKI

Study on the correlation between intestinal microbiota differential metabolites and the efficacy and gastrointestinal reactions of third-generation EGFR-TKI

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098640
Enrollment
Unknown
Registered
2025-03-11
Start date
2025-03-18
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Non-small cell lung cancer

Interventions

Gastrointestinal reactions occur group:None
No gastrointestinal reactions occurred group:None

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily participate in this study, fully understand, be informed about this study and sign the informed consent form; (2) Patients with primary non-small cell lung cancer confirmed by clear histopathological evidence; (3) Age 18~80 (inclusive) years old; ECOG score 0~1 points; (4) Have evaluable lesions on CT or MRI, and have at least one evaluation result; (5) The patient agrees to quit smoking and alcohol during the study period, and avoid spicy and irritating foods.

Exclusion criteria

Exclusion criteria: (1) Patients with autoimmune diseases and digestive diseases are excluded; (2) patients with secondary primary malignancies were excluded; (3) Patients who were treated with antibiotics, laxatives, immunosuppressants, microecological agents, etc. within 1 month were excluded; (4) Patients with infectious diseases such as viral hepatitis, HIV, syphilis, etc., are excluded; (5) Patients who need to be treated with high-dose hormones in the near future, active brain metastases that require treatment, and meningeal metastases are excluded.

Design outcomes

Primary

MeasureTime frame
Intestinal flora;

Secondary

MeasureTime frame
Metabolite;

Countries

China

Contacts

Public ContactChen Jun

The Second Affiliated Hospital of Dalian Medical University

chenjundl@vip.sina.com+86 1709873616

Outcome results

None listed

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