Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma.

Condition(s) studied

Investigational drug(s) / intervention(s)

FMT combined with chemotherapy plus immunotherapy: Drug: Fecal Microbiota Transplantation * Fecal Microbiota Transplantation with 80- 100 g of healthy donor stool in 36-40 oral capsules Drug: NALIRIFOX Chemotherapy * Liposomal Irinotecan 50mg/m²/day IV for every two weeks * Oxaliplatin 60 mg/m²/day IV for every two weeks * Leucovorin 400 mg/m²/ day IV for every two weeks * 5-FU 2400 mg/ m² day IV for every two weeks Drug: Immunotherapy * Serplulimab 3mg/kg day IV for every three weeks

Chemotherapy+Immunotherapy: Drug: NALIRIFOX Chemotherapy * Liposomal Irinotecan 50mg/m²/day IV for every two weeks * Oxaliplatin 60 mg/m²/day IV for every two weeks * Leucovorin 400 mg/m²/ day IV for every two weeks * 5-FU 2400 mg/ m² day IV for every two weeks Drug: Immunotherapy * Serplulimab 3mg/kg day IV for every three weeks

Study summary

This single center, prospective, randomized, open-label, two-arm parallel-controlled Phase II clinical trial is designed to evaluate the efficacy and safety of fecal microbiota transplantation （FMT ）combined with Nalirifox plus Serplulimab as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)

Eligibility

Primary outcome measure(s)

• Median Progression-Free Survival （mPFS） — From the first administration of study treatment dose of FMT until radiographic disease progression or death from any cause, whichever occurs first, up to approximately 1 year.
  The primary outcome will be median progression-free survival (mPFS), defined as the time from the date of first administration of study treatment to the first occurrence of objectively documented disease progression or death from any cause, whichever occurs first. mPFS will be used to evaluate the potential antitumor activity of FMT combined with Nalirifox plus serplulimab in treatment-naïve patients with locally advanced pancreatic ductal adenocarcinoma (PDAC). Tumor response and disease progression will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Radiographic assessments will be performed at baseline and subsequently every 9 weeks （±1 week） during the treatment period.

Trial sites (1)

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