Phase 2Not yet recruiting
FMT Plus SHR-1701 With Nab-Paclitaxel/Gemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
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
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital (Academic or other)
- Enrolment
- 60 planned
- Conditions
- Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- Interventions
- FMT+Chemotherapy+Immunotherapy; Chemotherapy+Immunotherapy
- Ages
- adults, older adults
- Registry
- NCT07845565
Full record on ClinicalTrials.gov
From the registry
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）.
Primary outcomes
- Median Progression-Free Survival (mPFS)
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered