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Effect of intestinal microbiome diversity on the efficacy and survival of chemotherapy for advanced non-small cell lung cancer

Effect of intestinal microbiome diversity on the efficacy and survival of chemotherapy for advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028186
Enrollment
Unknown
Registered
2019-12-14
Start date
2019-12-10
Completion date
Unknown
Last updated
2019-12-16

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

None Response Group:Nil

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with stage IV and no brain metastases by Shanghai Pulmonary Hospital after December 2019; 2. NSCLC confirmed by cytology or histology biopsy; 3. No sensitive gene mutations detected by genetic testing EGFR (-), ALK (-), KRAS (-), BRAF (-), ROS1 (-); 4. Aged 18-70 years old; 5. Expected survival time is more than 3 months; 6. ECOG (Eastern Cooperative Oncology Group, ECOG) Physical fitness score is 0 or 1; 7. Hemoglobin in peripheral blood >=100g/L, neutrophil count >=2.0*10^9/L, platelet count >=100*10^9/L.

Exclusion criteria

Exclusion criteria: 1. Severe or uncontrollable systemic diseases; 2. History of tumors (except early cervical cancer, skin basal cell carcinoma, etc.); 3. Patients with difficulty swallowing or gastrointestinal obstruction; 4. Previous History of gastrointestinal surgery; 5. History of inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or indeterminate colitis; 6. Persistent, infectious gastroenteritis, colitis or gastritis; persistent or chronic diarrhea of unknown etiology; Clostridium difficile infection (relapse) or Helicobacter pylori infection (untreated); 7. Chronic constipation; 8. Use of the following drugs within the last three months: alkali Bismuth salicylate and other similar bismuth basic salicylate drugs; 9. After evaluation, the researcher believes that the study is not good for patients and is not suitable for other conditions in the study.

Design outcomes

Primary

MeasureTime frame
CR;PR;SD;PD;PFS;OS;Gut microbiome;Fecal metabolomics;Immune factor;

Secondary

MeasureTime frame
Compliacation;

Countries

China

Contacts

Public ContactChang Chen

Shanghai Pulmonary Hospital

1931176@tongji.edu.cn+86 021-65115006

Outcome results

None listed

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