FMT Plus SHR-1701 With Nab-Paclitaxel/Gemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma：A Phase II Study:

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 microbiota transplantation （FMT） with Nab-paclitaxel plus Gemcitabine and as first-line treatment in patients for locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）.

Main inclusion criteria 1）18-75 years 2）Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that is locally advanced, unresectable with no prior systemic therapy for advanced disease. 3）At least one measurable lesion per RECIST v1.1. 4）Adequate hematologic, hepatic, renal, cardiac and coagulation function. 5）Have the ability to ingest capsule. 6）ECOG performance status of 0-1 7）Life expectancy of at least 3 months Main exclusion criteria 1. Patients with metastatic disease, peritoneal metastasis, malignant ascites, or unsuitable for NALIRIFOX treatment. 2. Patients with active autoimmune diseases or requiring systemic immunosuppressive therapy and patients with immunodeficiency, HIV infection, or history of organ/hematopoietic stem cell transplantation. 3. Patients with uncontrolled infection, active hepatitis B/C infection, or severe infectious diseases. 4. Patients with gastrointestinal perforation, fistula, abscess, active bleeding, or contraindications to FMT. 5. Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction. 6. Patients with known hypersensitivity to study drugs or FMT-related components.