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)
Age ≥18 years
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that is locally advanced, unresectable with no prior systemic therapy for advanced disease.
At least one measurable lesion per RECIST v1.1.
Adequate hematologic, hepatic, renal, and coagulation function per protocol-defined laboratory criteria, and no clinically significant electrocardiographic abnormalities.
Patients with metastatic disease, peritoneal metastasis, malignant ascites, or unsuitable for NALIRIFOX treatment.
Patients with active autoimmune diseases or requiring systemic immunosuppressive therapy and patients with immunodeficiency, HIV infection, or history of organ/hematopoietic stem cell transplantation.
Patients with uncontrolled infection, active hepatitis B/C infection, or severe infectious diseases.
Patients with gastrointestinal perforation, fistula, abscess, active bleeding, or contraindications to FMT.
Parallel
FMT combined with chemotherapy plus immunotherapy
DrugDrug: 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
DrugDrug: 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
Median Progression-Free Survival （mPFS）
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.
Objective Response Rate （ORR）
ORR will be defined as the proportion of participants whose best overall response (BOR) during study treatment is either complete response (CR) or partial response (PR), as assessed according to RECIST v1.1. Determined using RECIST 1.1 criteria to evaluate changes in tumour size on routine imaging and quantified using the Kaplan-Meier method.
Disease Control Rate （DCR）
DCR will be defined as the proportion of participants whose best overall response is CR, PR, or stable disease （SD） according to RECIST v1.1.
Duration of Response （DoR）
DoR will be defined as the time from the date of the first documented CR or PR to the first assessed progressive disease (PD) or death from any cause, whichever occurs first. Duration of response will be evaluated among participants who achieve an objective response.
Overall Survival （OS）
OS will be defined as the time from the date of first administration of study treatment to death from any cause. For participants who remain alive at the time of the last follow-up, OS will be censored at the date on which the participant was last confirmed to be alive. Participants who are lost to follow-up, OS will be censored at the date of the last confirmed survival assessment.
Changes in patient gut microbiome composition following FMT
Changes in patient gut microbiome will be determined by analysis of gut bacterial composition in patient stool samples at baseline and post-FMT.
Multi-Omics prognosis biomarker Profiles
Changes from baseline in prespecified metabolomic and immune-related biomarkers measured using metabolomic analysis and immunological assays, respectively, and their associations with clinical and associated mechanisms.
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