Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:Fecal microbiota transplantation (FMT) combined with platinum-based chemotherapy and PD-1/PD-L1 inhibitors
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 75 years, with no restriction on sex. (2) Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC). (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1. (4) No known driver gene mutations (e.g., EGFR, ALK). (5) No prior systemic anti-tumor therapy. (6) Planned to receive first-line standard treatment with platinum-based chemotherapy (carboplatin or cisplatin) in combination with a PD-1 inhibitor (tislelizumab). (7) Eligible for and willing to undergo fecal microbiota transplantation (FMT). (8) Expected survival of >=3 months. (9) Body weight >=30 kg. (10) No prior exposure to anti-angiogenic agents. (11) Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC) >= 1.5 × 10?/L, platelet count >= 100 × 10?/L, hemoglobin >= 9.0 g/dL, total bilirubin <= 1.5 × the upper limit of normal (ULN), ALT and AST <= 2.5 × ULN (or <= 5 × ULN in patients with liver metastases), international normalized ratio (INR) and prothrombin time (PT) <= 1.5 × ULN (for patients not receiving anticoagulant therapy). (12) Voluntarily signs the informed consent form with good compliance.
Exclusion criteria
Exclusion criteria: Tumor-related criteria (1) Diagnosis of limited-stage small cell lung cancer (LS-SCLC) or combined histology small cell lung cancer. (2) Prior receipt of any systemic cancer therapy. (3) Inability to tolerate oral administration (e.g., severe dysphagia, gastrointestinal obstruction, chronic diarrhea). (4) Active autoimmune disease or immunodeficiency. (5) Use of immunosuppressive drugs within 14 days prior to first study treatment. (6) Significant hepatic or renal dysfunction. (7) Active tuberculosis or other uncontrolled infections. (8) Pregnant or breastfeeding women. (9) Concurrent participation in another interventional clinical trial. FMT-related criteria (1) Severe impairment of the intestinal mucosal barrier (e.g., sepsis, active gastrointestinal bleeding, perforation, ulceration) with high risk of enterogenic infection. (2) Current diagnosis of fulminant colitis or toxic megacolon. (3) Inability to tolerate >=50% of caloric requirements via enteral nutrition due to severe diarrhea, significant fibrotic intestinal strictures, severe gastrointestinal bleeding, or high-output intestinal fistula. (4) Severe immunosuppression: absolute neutrophil count < 1500/mm³ in adults, lymphocyte count < 500/mm³, or absolute neutrophil count < 1000/mm³ in children. (5) Contraindications to the FMT delivery procedure itself (including endoscopy, catheterization, enema, or oral administration) or presence of obstructed delivery routes. (6) Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Incidence of Adverse Events,iAE;Quality of Life Questionnaire Score; | — |
Countries
China
Contacts
Public ContactTian Ma
General Hospital of Ningxia Medical University
Outcome results
None listed