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

NCT07845565 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: E20260979
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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）.

Conditions

Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Fecal Microbial Transplantation （FMT）; Pancreatic Ductal Adenocarcinoma (PDAC); Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; SHR-1701; PD-L1/TGF-βRII Fusion Protein; Nab-Paclitaxel; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (5)

• Objective Response Rate （ORR）

  From the first dose of study treatment until documented disease progression or initiation of a new anticancer therapy, assessed up to 12 months.

• Disease Control Rate （DCR）

  From the first dose of study treatment until documented disease progression or initiation of a new anticancer therapy, assessed up to 12 months.

• Duration of Response (DoR)

  From the first documented complete or partial response until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months.

• Overall Survival (OS)

  From the first dose of study treatment until death from any cause, assessed up to 36 months.

• Safety and Adverse Events

  30 days

Study Arms (2)

FMT+Chemotherapy+Immunotherapy

EXPERIMENTAL

Bowel preparation with Polyethylene Glycol is administered on Day 0, followed by Fecal Microbiota Transplantation （FMT） on Day 1. AG is administered intravenously at Day8，Day15 and Day 22 of each 28 days. SHR-1701 is also initiated on Day 8 and administered intravenously once every 3 weeks, with FMT given concurrently with each SHR-1701.If the patient's disease is assessed as not having progressed, the current treatment regimen will be continued. For patients with stable or partial or complete response, the current treatment regimen will be continued in accordance with the study protocol.

Drug: FMT+Chemotherapy+Immunotherapy

Chemotherapy+Immunotherapy

OTHER

AG is administered intravenously at Day8，Day15 and Day 22 of each 28 days. SHR-1701 is also started on Day 8 and administered intravenously once every 3 weeks, for patients with stable or partial or complete response, the current treatment regimen will be continued in accordance with the study protocol.

Drug: Chemotherapy+Immunotherapy

Interventions

Chemotherapy+Immunotherapy DRUG

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

FMT+Chemotherapy+Immunotherapy DRUG

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

FMT+Chemotherapy+Immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have the ability to ingest capsule.
• ECOG performance status of 0-1
• Life expectancy of at least 3 months

You may not qualify if:

• 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.
• Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction.
• Patients with known hypersensitivity to study drugs or FMT-related components.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

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Study Officials

• Hao Jihui, MD, PhD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Zhang Ningning, MD, PhD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Ningning, MD, PhD

CONTACT

+8615822153931; mail4ningning@163.com

Yu Hao, PhD

CONTACT

+8613012284232; tijmuyh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

CN (1)