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FMT Plus SHR-1701 With Nab-Paclitaxel/Gemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
This is a prospective, single-center, randomized, open-label, two-arm Phase II clinical trial design to evaluate the feasibility, safety and preliminary efficacy of combining fecal Fecal Microbiota Transplantation （FMT） Combined With SHR-1701plus Nab-paclitaxel and Gemcitabine as first-line treatment in patients for locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）.
Official title: Fecal Microbiota Transplantation Combined With SHR-1701(an Anti-PD-L1/TGF-βRII Fusion Protein) and Nab-Paclitaxel Plus Gemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma：A Randomized, Open-Label, Single-Center, Two-Arm, Prospective Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-11
Completion Date
2030-05
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
FMT+Chemotherapy+Immunotherapy
Drug: Fecal Microbiota Transplantation * Fecal Microbiota Transplantation with 80- 100 g of healthy donor stool in 36-40 oral capsules Drug :AG Chemotherapy * Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. * nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Drug: Immunotherapy * SHR-1701 30mg/kg IV every 3 week
Chemotherapy+Immunotherapy
Drug :AG Chemotherapy * Gemcitabine 1000 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. * nab-Paclitaxel 125 mg/m2/day IV on Days 1, 8, and 15 of each 28-day cycle. Drug: Immunotherapy * SHR-1701 30mg/kg IV every 3 week
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China