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An exploratory study of fecal microbiota transplantation in first-line maintenance therapy for advanced gastric cancer and lung cancer

An exploratory study of fecal microbiota transplantation in first-line maintenance therapy for advanced gastric cancer and lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054928
Enrollment
Unknown
Registered
2021-12-29
Start date
2022-01-10
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Gastric cancer and lung cancer

Interventions

Group 1:TP+FMT
Group 2:SOX+FMT

Sponsors

Changzhou Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. (1) Gastric cancer group: unresectable advanced gastric/gastroesophageal carcinoma confirmed by histopathological age and/or cytology; (2) lung cancer group: unresectable advanced non-small cell lung cancer confirmed by histopathological age and/or cytology; 2. ECOG score 0-1; 3. There has been no systemic intravenous anti-tumor therapy in the past; 4. Aged 18-90 years; 5. Patients have at least one measurable lesion according to RECIST 1.1 standard; 6. Estimated survival time >= 4 months.

Exclusion criteria

Exclusion criteria: 1. Unable to cooperate with mental illness; 2. Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplant; 3. Use large doses of glucocorticoids or immune transplants within 4 weeks; 4. Complicated with other malignant tumors; 5. Patients who participate in other clinical trials within 4 weeks; 6. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need to use corticosteroids; 7. Have a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus; a history of inflammatory bowel diseases such as ulcerative enteritis and Crohn's disease; a history of chronic diarrheal diseases such as irritable bowel syndrome; a history of sarcoidosis or tuberculosis; 8. Patients who do not follow the doctor's advice, do not take medicine in accordance with the regulations, or have incomplete data, such as those who can affect the judgment of efficacy or safety; 9. According to the judgment of the researchers, there are serious hazards to the safety of patients or concomitant diseases that affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactJiang Hua

Changzhou Second People's Hospital

czeyjh@njmu.edu.cn+86 18015852711

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026