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）.
18-75 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, cardiac and coagulation function.
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+Chemotherapy+Immunotherapy
DrugDrug: 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
DrugDrug :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
Median Progression-Free Survival (mPFS)
The primary efficacy 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 SHR-1701 and nab-paclitaxel Plus Gemcitabine in the 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） from the beginning of the treatment until the first objective tumor progression throughout the entire study.
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.
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