Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07845565
FMT Plus SHR-1701 With Nab-Paclitaxel/Gemcitabine as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing FMT+Chemotherapy+Immunotherapy and Chemotherapy+Immunotherapy in people with Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- FMT+Chemotherapy+Immunotherapy and Chemotherapy+Immunotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to May 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Have the ability to ingest capsule.
- ECOG performance status of 0-1
- Life expectancy of at least 3 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Zhang Ningning, MD, PhD, +8615822153931, mail4ningning@163.com
Liu Yue, PhD, liuxiaotian116@163.com
About this study
Official title: 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
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）.
Read the detailed description
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.
- Being tested
- FMT+Chemotherapy+Immunotherapy, Chemotherapy+Immunotherapy
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT+Chemotherapy+ImmunotherapyDrug
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+ImmunotherapyDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Chemotherapy+Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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）
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.
Measured: 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）
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.
Measured: 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)
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
Measured: 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)
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.
Measured: From the first dose of study treatment until death from any cause, assessed up to 36 months.
Safety and Adverse Events
Safety and tolerability of the treatment strategy will be evaluated based on the incidence, severity, and characteristics of adverse events （AEs） occurring during the study. Safety analyses will include:
All treatment-emergent adverse events; Treatment-related adverse events; Serious adverse events （SAEs); Treatment-related SAEs; Clinically significant laboratory abnormalities; and Changes in vital signs, physical examination findings, and ECG and laboratory abnormalities
Safety assessments will be conducted from baseline through 30 days （±7 days） after the final administration of study treatment, with ongoing follow-up of clinically significant unsolved events according to the study protocol.
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI.CTCAE).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Jihui, MD, PhD, Principal investigator, Tianjin Medical University Cancer Institute and HospitalZhang Ningning, MD, PhD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845565
- Sponsor's protocol ID
- E20260979
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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PubMed 33303685Davar D, Dzutsev AK, McCulloch JA, Rodrigues RR, Chauvin JM, Morrison RM, Deblasio RN, Menna C, Ding Q, Pagliano O, Zidi B, Zhang S, Badger JH, Vetizou M, Cole AM, Fernandes MR, Prescott S, Costa RGF, Balaji AK, Morgun A, Vujkovic-Cvijin I, Wang H, Borhani AA, Schwartz MB, Dubner HM, Ernst SJ, Rose A, Najjar YG, Belkaid Y, Kirkwood JM, Trinchieri G, Zarour HM. Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients. Science. 2021 Feb 5;371(6529):595-602. doi: 10.1126/science.abf3363.
PubMed 33542131Geller LT, Barzily-Rokni M, Danino T, Jonas OH, Shental N, Nejman D, Gavert N, Zwang Y, Cooper ZA, Shee K, Thaiss CA, Reuben A, Livny J, Avraham R, Frederick DT, Ligorio M, Chatman K, Johnston SE, Mosher CM, Brandis A, Fuks G, Gurbatri C, Gopalakrishnan V, Kim M, Hurd MW, Katz M, Fleming J, Maitra A, Smith DA, Skalak M, Bu J, Michaud M, Trauger SA, Barshack I, Golan T, Sandbank J, Flaherty KT, Mandinova A, Garrett WS, Thayer SP, Ferrone CR, Huttenhower C, Bhatia SN, Gevers D, Wargo JA, Golub TR, Straussman R. Potential role of intratumor bacteria in mediating tumor resistance to the chemotherapeutic drug gemcitabine. Science. 2017 Sep 15;357(6356):1156-1160. doi: 10.1126/science.aah5043.
PubMed 28912244Riquelme E, Zhang Y, Zhang L, Montiel M, Zoltan M, Dong W, Quesada P, Sahin I, Chandra V, San Lucas A, Scheet P, Xu H, Hanash SM, Feng L, Burks JK, Do KA, Peterson CB, Nejman D, Tzeng CD, Kim MP, Sears CL, Ajami N, Petrosino J, Wood LD, Maitra A, Straussman R, Katz M, White JR, Jenq R, Wargo J, McAllister F. Tumor Microbiome Diversity and Composition Influence Pancreatic Cancer Outcomes. Cell. 2019 Aug 8;178(4):795-806.e12. doi: 10.1016/j.cell.2019.07.008.
PubMed 31398337Pushalkar S, Hundeyin M, Daley D, Zambirinis CP, Kurz E, Mishra A, Mohan N, Aykut B, Usyk M, Torres LE, Werba G, Zhang K, Guo Y, Li Q, Akkad N, Lall S, Wadowski B, Gutierrez J, Kochen Rossi JA, Herzog JW, Diskin B, Torres-Hernandez A, Leinwand J, Wang W, Taunk PS, Savadkar S, Janal M, Saxena A, Li X, Cohen D, Sartor RB, Saxena D, Miller G. The Pancreatic Cancer Microbiome Promotes Oncogenesis by Induction of Innate and Adaptive Immune Suppression. Cancer Discov. 2018 Apr;8(4):403-416. doi: 10.1158/2159-8290.CD-17-1134. Epub 2018 Mar 22.
PubMed 29567829Matson V, Fessler J, Bao R, Chongsuwat T, Zha Y, Alegre ML, Luke JJ, Gajewski TF. The commensal microbiome is associated with anti-PD-1 efficacy in metastatic melanoma patients. Science. 2018 Jan 5;359(6371):104-108. doi: 10.1126/science.aao3290.
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