Locally Advanced Pancreatic Ductal AdenocarcinomaPhase 2NCT07854977
Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma.
A Phase 2 study testing FMT combined with chemotherapy plus immunotherapy and Chemotherapy+Immunotherapy in people with Locally Advanced Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This single center, prospective, randomized, open-label, two-arm parallel-controlled Phase II clinical trial is designed to evaluate the efficacy and safety of fecal microbiota transplantation （FMT ）combined with Nalirifox plus Serplulimab as first-line treatment in patients with locally advanced or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- FMT combined with chemotherapy plus 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
- 40 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 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, and coagulation function per protocol-defined laboratory criteria, and no clinically significant electrocardiographic abnormalities.
- Able to swallow capsules whole, and no systemic broad-spectrum antibiotic use within the protocol-defined washout period prior to enrollment.
- ECOG performance status of 0 or 1, and 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
Liu Yue, PhD, +8615245104487, liuxiaotian116@163.com
Hao Jihui, MD, PhD
About this study
Official title: Fecal Microbiota Transplantation Combined With NALIRIFOX Plus Serplulimab as First-line Treatment for Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Randomized, Open-Label, Single-Center, Parallel-Group, Prospective Phase II Clinical Study.
This single center, prospective, randomized, open-label, two-arm parallel-controlled Phase II clinical trial is designed to evaluate the efficacy and safety of fecal microbiota transplantation （FMT ）combined with Nalirifox plus Serplulimab as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
Read the detailed description
The main purpose of this phase II study is to assess the efficacy and safety of fecal microbiota transplantation （FMT） combined with NALIRIFOX plus Serplulimab as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC).
This study plans to enroll a total of 40 treatment-naïve patients diagnosed with locally advanced or metastatic PDAC and will be randomized in a 1:1 ratio to either the experimental group (group A, n=20） or the other group (group B, n=20）.
The primary objective is to evaluate the median progression-free survival （mPFS） of fecal microbiota transplantation （FMT） combined with NALIRIFOX plus Serplulimab in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma （PDAC）.
Secondary objectives are to determine the overall survival （OS）, objective response rate, disease control rate （DCR）, and duration of response （DoR） according to RECIST v1.1 criteria. Adverse drug events （ADEs) will be evaluated and graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events ( NCI-CTCAE) version 6.0.
In addition, this study aims to investigate multi-omics prognosis prediction biomarkers and their underlying mechanisms.
- Conditions
- Locally Advanced Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- FMT combined with chemotherapy plus immunotherapy, Chemotherapy+Immunotherapy
- Keywords
- Fecal Microbial Transplantation, Nalirifox, Serplulimab, Liposomal Irinotecan, Oxaliplatin, Leucovorin, 5-Fluorouracil (5-FU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT combined with chemotherapy plus immunotherapyDrug
Drug: Fecal Microbiota Transplantation
- Fecal Microbiota Transplantation with 80- 100 g of healthy donor stool in 36-40 oral capsules Drug: NALIRIFOX Chemotherapy
- Liposomal Irinotecan 50mg/m²/day IV for every two weeks
- Oxaliplatin 60 mg/m²/day IV for every two weeks
- Leucovorin 400 mg/m²/ day IV for every two weeks
- 5-FU 2400 mg/ m² day IV for every two weeks Drug: Immunotherapy
- Serplulimab 3mg/kg day IV for every three weeks
Chemotherapy+ImmunotherapyDrug
Drug: NALIRIFOX Chemotherapy
- Liposomal Irinotecan 50mg/m²/day IV for every two weeks
- Oxaliplatin 60 mg/m²/day IV for every two weeks
- Leucovorin 400 mg/m²/ day IV for every two weeks
- 5-FU 2400 mg/ m² day IV for every two weeks Drug: Immunotherapy
- Serplulimab 3mg/kg day IV for every three weeks
| Study group | Role | What they receive |
|---|---|---|
| FMT+Chemotherapy+Immunotherapy | Experimental | Polyethylene glycol bowel preparation will be performed on Day 0, followed by FMT administration on Day 1. Starting on Day 8, Nalirifox will be administered intravenously once every 14 days, and serplulimab will be administered intravenously once every 3 weeks. Two additional FMT administrations will be given concurrently with ICI administration.
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 combined with chemotherapy plus immunotherapy |
| Chemotherapy+Immunotherapy | Other | Starting on Day 8, Nalirifox will be administered intravenously once every 14 days for 4 cycles, and serplulimab will be administered intravenously once every 3 weeks for 3 cycles. Two additional FMT administrations will be given concurrently with ICI administration. 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 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 Nalirifox plus serplulimab in 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 administration of study treatment dose of FMT until radiographic disease progression or death from any cause, whichever occurs first, up to approximately 1 year.
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), as assessed according to RECIST v1.1.
Determined using RECIST 1.1 criteria to evaluate changes in tumour size on routine imaging and quantified using the Kaplan-Meier method.
Measured: From the first administration of study treatment dose of FMT until radiographic disease progression or death from any cause, whichever occurs first, up to approximately 1 year.
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: Starting from the first administration of study treatment dose of FMT to radiographic disease progression or death, up to approximately 1 year
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: Starting from the first administration of study treatment dose of FMT to radiographic disease progression or death, up to approximately 1 year.
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: Starting from the first administration of study treatment dose of FMT to radiographic disease progression or death, up to approximately 1 year.
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 electrocardiographic parameters.
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 posted2 Oct 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 (19)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Pancreatic Ductal AdenocarcinomaStudies 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
- 40 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, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854977
- Sponsor's protocol ID
- IRB20260165
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Renouf DJ, Loree JM, Knox JJ, Topham JT, Kavan P, Jonker D, Welch S, Couture F, Lemay F, Tehfe M, Harb M, Aucoin N, Ko YJ, Tang PA, Ramjeesingh R, Meyers BM, Kim CA, Du P, Jia S, Schaeffer DF, Gill S, Tu D, O'Callaghan CJ. The CCTG PA.7 phase II trial of gemcitabine and nab-paclitaxel with or without durvalumab and tremelimumab as initial therapy in metastatic pancreatic ductal adenocarcinoma. Nat Commun. 2022 Aug 26;13(1):5020. doi: 10.1038/s41467-022-32591-8.
PubMed 36028483DeFilipp Z, Bloom PP, Torres Soto M, Mansour MK, Sater MRA, Huntley MH, Turbett S, Chung RT, Chen YB, Hohmann EL. Drug-Resistant E. coli Bacteremia Transmitted by Fecal Microbiota Transplant. N Engl J Med. 2019 Nov 21;381(21):2043-2050. doi: 10.1056/NEJMoa1910437. Epub 2019 Oct 30.
PubMed 31665575Baruch EN, Youngster I, Ben-Betzalel G, Ortenberg R, Lahat A, Katz L, Adler K, Dick-Necula D, Raskin S, Bloch N, Rotin D, Anafi L, Avivi C, Melnichenko J, Steinberg-Silman Y, Mamtani R, Harati H, Asher N, Shapira-Frommer R, Brosh-Nissimov T, Eshet Y, Ben-Simon S, Ziv O, Khan MAW, Amit M, Ajami NJ, Barshack I, Schachter J, Wargo JA, Koren O, Markel G, Boursi B. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science. 2021 Feb 5;371(6529):602-609. doi: 10.1126/science.abb5920. Epub 2020 Dec 10.
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.
PubMed 29302014Gopalakrishnan V, Spencer CN, Nezi L, Reuben A, Andrews MC, Karpinets TV, Prieto PA, Vicente D, Hoffman K, Wei SC, Cogdill AP, Zhao L, Hudgens CW, Hutchinson DS, Manzo T, Petaccia de Macedo M, Cotechini T, Kumar T, Chen WS, Reddy SM, Szczepaniak Sloane R, Galloway-Pena J, Jiang H, Chen PL, Shpall EJ, Rezvani K, Alousi AM, Chemaly RF, Shelburne S, Vence LM, Okhuysen PC, Jensen VB, Swennes AG, McAllister F, Marcelo Riquelme Sanchez E, Zhang Y, Le Chatelier E, Zitvogel L, Pons N, Austin-Breneman JL, Haydu LE, Burton EM, Gardner JM, Sirmans E, Hu J, Lazar AJ, Tsujikawa T, Diab A, Tawbi H, Glitza IC, Hwu WJ, Patel SP, Woodman SE, Amaria RN, Davies MA, Gershenwald JE, Hwu P, Lee JE, Zhang J, Coussens LM, Cooper ZA, Futreal PA, Daniel CR, Ajami NJ, Petrosino JF, Tetzlaff MT, Sharma P, Allison JP, Jenq RR, Wargo JA. Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients. Science. 2018 Jan 5;359(6371):97-103. doi: 10.1126/science.aan4236. Epub 2017 Nov 2.
PubMed 29097493Routy B, Le Chatelier E, Derosa L, Duong CPM, Alou MT, Daillere R, Fluckiger A, Messaoudene M, Rauber C, Roberti MP, Fidelle M, Flament C, Poirier-Colame V, Opolon P, Klein C, Iribarren K, Mondragon L, Jacquelot N, Qu B, Ferrere G, Clemenson C, Mezquita L, Masip JR, Naltet C, Brosseau S, Kaderbhai C, Richard C, Rizvi H, Levenez F, Galleron N, Quinquis B, Pons N, Ryffel B, Minard-Colin V, Gonin P, Soria JC, Deutsch E, Loriot Y, Ghiringhelli F, Zalcman G, Goldwasser F, Escudier B, Hellmann MD, Eggermont A, Raoult D, Albiges L, Kroemer G, Zitvogel L. Gut microbiome influences efficacy of PD-1-based immunotherapy against epithelial tumors. Science. 2018 Jan 5;359(6371):91-97. doi: 10.1126/science.aan3706. Epub 2017 Nov 2.
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PubMed 39455872