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Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma.
Sponsor: Tianjin Medical University Cancer Institute and Hospital
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)
Official title: Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Randomized, Open-Label, Single-Center, Parallel-Group, Prospective Phase II Clinical Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-11
Completion Date
2030-05
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China