Phase 2Not yet recruiting
Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma.
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.
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital (Academic or other)
- Enrolment
- 40 planned
- Conditions
- Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- Interventions
- FMT combined with chemotherapy plus immunotherapy; Chemotherapy+Immunotherapy
- Ages
- adults, older adults
- Registry
- NCT07854977
Full record on ClinicalTrials.gov
From the registry
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)
Primary outcomes
- Median Progression-Free Survival （mPFS）
History
Study completion expected
Primary completion expected
Expected to start
Registered