Fecal Microbiota Transplantation Shows Promise in Combating Advanced Small Cell Lung Cancer

Researchers at the General Hospital of Ningxia Medical University have initiated a clinical trial to investigate the efficacy of Fecal Microbiota Transplantation (FMT) combined with platinum-based chemotherapy and immunotherapy in treating advanced small cell lung cancer (SCLC). The trial aims to evaluate the safety and tolerability of this combined regimen, as well as its impact on progression-free survival, overall survival, and objective response rate.

Key Takeaways:

  • The clinical trial aims to assess the safety and tolerability of FMT combined with platinum-based chemotherapy and immunotherapy as a first-line treatment for advanced SCLC, with the primary objective of evaluating adverse events and patient tolerability.
  • The trial also aims to explore the impact of the combined treatment regimen on progression-free survival (PFS) and overall survival (OS), with a secondary objective of comparing PFS and OS with historical control data or current standard-of-care outcomes.
  • The study will involve 120 patients with advanced SCLC, with follow-up for up to 2 years after treatment initiation.
  • Fecal samples will be collected from patients before and after treatment for metagenomic sequencing or 16S rRNA sequencing to analyze the composition and diversity of gut microbiota.
  • Concurrently, peripheral blood immune cell subset profiling and cytokine level measurement will be performed to examine the relationship between gut microbial changes and host immune responses.
  • The study seeks to elucidate the potential mechanisms by which FMT modulates the immune microenvironment and enhances anti-tumor immune responses.
  • The clinical trial registration number is ChiCTR2500107861.

Statistics:

  • The trial aims to recruit 120 patients with advanced SCLC.
  • The study will involve a minimum of 2 years of follow-up after treatment initiation.
  • Fecal samples will be collected from patients before treatment (0 days) and after treatment (30-60 days, and 90-120 days).
  • The study will assess the impact of FMT on gut microbiota and immune response in patients with advanced SCLC.

Sources:

  • Chinese Clinical Trial Registry. (2023). Fecal Microbiota Transplantation Combined with Platinum-Based Chemotherapy and Immunotherapy was used Safety and Initial Treatment of First-Line Treatment in Patients with Advanced Small Cell Lung Cancer Effectiveness Research. ChiCTR2500107861.