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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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）.

Eligibility

Primary outcome measure(s)

• Median Progression-Free Survival (mPFS) — From the first dose of study treatment until the first documented radiographic disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed up to 12 months.
  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.

Trial sites (1)

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