Pancreatic Cancer Research

Clinical trialPhase 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

NCT07845565↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Ongoing
Phase
Phase 2
Status
Not yet recruiting
Study type
Interventional
Start
November 2026
Expected end
May 2030
Enrollment
60 participants
Sites
1
Primary outcomes
Median Progression-Free Survival (mPFS)
Sponsor
Other
Results posted
No
Last update
1 October 2026

These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.

Ask this document

Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.

Try

Source text

Brief summary public domain (ClinicalTrials.gov)

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）.

Detailed description public domain (ClinicalTrials.gov)

This phase II study aims to assess the efficacy and safety of fecal microbiota transplantation （FMT) combined with SHR-1701plus Nab-paclitaxel and Gemcitabine as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC). This study plans to enroll a total of 60 treatment-naïve patients diagnosed with locally advanced or metastatic PDAC and participants will be randomized in a 1:1 ratio into experimental group (group A, n=30）or control group (group B, n=30） The primary objective is to evaluate the median progression free-survival （mPFS） of fecal microbiota transplantation （FMT） combined with SHR-1701 Plus AG chemotherapy in patients for locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）. The secondary objectives are to determine the overall survival （OS）, objective response rate （ORR）, disease control rate （DCR）, and duration of response （DoR） according to RECIST v1.1 criteria. Furthermore, to assess adverse drug events （ADEs） and other reported adverse events will be evaluated and graded in based on the NCI-CTCAE, version 6.0. As exploratory objectives, this study aims to investigate multi-omics prognosis prediction biomarkers and their associated mechanisms.

Papers 11