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Effects of intestinal microbiome diversity on the efficacy and survival of chemotherapy combined with immunotherapy and immunotherapy in advanced non-small cell lung cancer

Effects of intestinal microbiome diversity on the efficacy and survival of chemotherapy combined with immunotherapy and immunotherapy in advanced non-small cell lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028208
Enrollment
Unknown
Registered
2019-12-15
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

Group 1:Chemotherapy combined with immunotherapy

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Lung cancer patients diagnosed with stage IV without brain metastases confirmed by Shanghai Pulmonary Hospital after December 2019; (2) NSCLC confirmed by cytology or histology biopsy; (3) genetic testing showed No sensitive gene mutations EGFR (-), ALK (-), KRAS (-), BRAF (-), ROS1 (-)); (4) Aged 18-70 years old; (5) Estimated survival time is more than 3 months; (6) ECOG (Eastern Cooperative Oncology Group, ECOG) physical fitness score of 0 or 1; (7) hemoglobin in peripheral blood >=100g/L, neutrophil count >= 2.0*10^9/L, platelets The count is >= 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