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Unresectable Colorectal CancerPhase 2/3NCT07509398

FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer

A Phase 2/3 study testing Standard First-Line Therapy and FMT Combined with Standard First-Line Therapy in people with Unresectable Colorectal Cancer and Colorectal Cancer (Locally Advanced or Metastatic), run by Shanghai 10th People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical trial evaluates the efficacy and safety of adding fecal microbiota transplantation (FMT) to first-line standard of care for patients with initially unresectable colorectal cancer (CRC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Standard First-Line Therapy and FMT Combined with Standard First-Line Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
No sites listed yet
Study dates
Apr 2026to Dec 2031
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • (1) Subjects must volunteer to participate in this study, sign the informed consent form (ICF), and demonstrate good compliance.
  • Patients aged 18 to 75 years (inclusive). (3) Meet the defined criteria for initially unresectable advanced metastatic colorectal cancer (mCRC) for this project.
  • Have not received first-line standard therapy. (5) Prior radiotherapy is permitted, provided it was completed more than 4 weeks prior to enrollment.
  • ECOG performance status of 0 to 1. (7) Life expectancy of ≥ 24 weeks. (8) Adequate major organ function meeting the following criteria (without the use of any blood components or cell growth factors within 2 weeks prior to enrollment): (9) Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, white blood cell (WBC) count ≥ 4.0 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L.
  • Hepatic function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); if total bilirubin > 1.5 × ULN, direct bilirubin must be ≤ ULN. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (allowed up to 5 × ULN for patients with liver metastases).
  • Renal function: Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL/min).
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  • Cardiac function: Normal cardiac function with a left ventricular ejection fraction (LVEF) ≥ 50%.
  • Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • Male or female patients of childbearing potential must volunteer to use effective contraceptive methods (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices) during the study and for 6 months after the last dose of study medication. All female patients are considered to be of childbearing potential unless they are naturally postmenopausal, artificially postmenopausal, or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or pelvic irradiation). Otherwise, female patients must have a negative serum pregnancy test (within 7 days prior to study enrollment) and must not be lactating.

Who cannot join

  • (1) Presence of symptoms such as bleeding, perforation, or obstruction at the primary tumor site.
  • Presence of secondary intracranial tumors (brain metastases). (3) History of severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.
  • Symptomatic interstitial lung disease, or active infectious/non-infectious pneumonitis.
  • Risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or other known risk factors for intestinal perforation.
  • Patients who have undergone other surgeries must wait for complete wound healing before being considered for enrollment.
  • History of other malignancies; except for cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and carcinoma in situ of the prostate, cervix, or breast, which are permitted for enrollment.
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  • Patients planning to undergo or who have previously undergone organ transplantation or allogeneic bone marrow transplantation.
  • Moderate to severe ascites with clinical symptoms requiring therapeutic paracentesis or drainage, or a Child-Pugh score > 2 (excluding cases with only a small amount of ascites shown on imaging without clinical symptoms); uncontrolled or moderate to large pleural or pericardial effusions.
  • History of gastrointestinal bleeding within 6 months prior to the start of study treatment or a clear tendency for gastrointestinal bleeding, such as esophageal/gastric varices with bleeding risk or severe varices, localized active gastrointestinal ulcer lesions, or persistently positive fecal occult blood (if fecal occult blood is positive at baseline, it can be retested; if still positive, an esophagogastroduodenoscopy (EGD) is required. If EGD indicates esophageal/gastric varices with a risk of bleeding, the patient cannot be enrolled).
  • Occurrence of an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment.
  • Patients who presented with signs/symptoms of incomplete obstruction/obstructive syndrome/ileus at initial diagnosis may be enrolled if the symptoms have completely resolved following definitive (surgical) treatment.
  • Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; current or recent (within 10 days prior to study treatment) use of full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin or low molecular weight heparin is allowed).
  • Current or recent (within 10 days prior to study treatment) use of aspirin (> 325 mg/day, maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel (≥ 75 mg), or cilostazol.
  • Occurrence of thrombotic or embolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
  • Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmias.
  • Lactating or pregnant women. (18) History of hepatic encephalopathy. (19) Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or equivalent) within 14 days prior to the start of study treatment.
  • Known severe allergic reaction to any monoclonal antibodies or anti-angiogenic targeted drugs.
  • Any other factors that, in the judgment of the investigator, may affect the study results or lead to premature termination of the study, such as alcohol abuse, drug abuse, other severe diseases (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qiyi Chen contact

+86 15896453859

qiyichen2011@163.com

About this study

Official title: Efficacy and Safety of Fecal Microbiota Transplantation Combined With First-Line Standard Therapy in Patients With Initially Unresectable Colorectal Cancer: A Multicenter, Open-Label, Randomized Controlled Trial

This clinical trial evaluates the efficacy and safety of adding fecal microbiota transplantation (FMT) to first-line standard of care for patients with initially unresectable colorectal cancer (CRC).

FMT is an established procedure designed to restore intestinal microbiome homeostasis by transferring processed fecal microbiota from a rigorously screened healthy donor into the patient's gastrointestinal tract. The standard first-line treatment regimen typically consists of chemotherapy, with or without targeted therapy.

Read more

Approximately 220 patients across 13 participating centers will be randomly assigned to receive either standard therapy alone or standard therapy combined with FMT. The primary endpoint is the objective response rate (ORR). Secondary endpoints include the conversion to resectability rate, progression-free survival (PFS), safety and adverse events, quality of life (QoL), anxiety and depression scales, as well as dynamic changes in the gut microbiome and circulating biomarkers.

The ultimate goal of this trial is to determine whether microbiome modulation via FMT can synergistically enhance the antitumor efficacy of standard first-line therapies and mitigate treatment-related toxicities in this patient population.

Being tested
Standard First-Line Therapy, FMT Combined with Standard First-Line Therapy
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard First-Line TherapyDrug

    Investigator's choice of standard first-line systemic therapy for initially unresectable colorectal cancer, including chemotherapy (e.g., FOLFOX, FOLFIRI, CAPOX) with or without targeted therapy or anti-angiogenic agents (e.g., cetuximab, panitumumab for RAS wild-type; bevacizumab for others), according to CSCO/NCCN guidelines and RAS mutation status.

  • FMT Combined with Standard First-Line TherapyCombination product

    Fecal microbiota transplantation using donor stool from healthy screened donors. Prepared under P2/GMP conditions as capsules or suspension. Administered in addition to standard therapy per study protocol (induction phase followed by maintenance).

Study groups in NCT07509398
Study groupRoleWhat they receive
Standard First-Line TherapyActive comparatorPatients receive investigator's choice of standard first-line systemic therapy for initially unresectable colorectal cancer (e.g., chemotherapy ± targeted therapy or anti-angiogenic agents according to CSCO/NCCN guidelines and RAS status).
Receives: Drug: Standard First-Line Therapy
FMT Combined with Standard First-Line TherapyExperimentalPatients receive fecal microbiota transplantation (FMT) in addition to the same standard first-line systemic therapy as in the control arm. FMT is administered according to the study protocol (donor-screened, prepared under GMP/P2 conditions, capsule delivery).
Receives: Drug: Standard First-Line Therapy; Combination Product: FMT Combined with Standard First-Line Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: Up to 12 months (from randomization to best overall response assessment)

Secondary outcomes (7)

  1. Conversion Resection Rate (R0)

    Proportion of participants who achieve R0 resection (microscopically negative margins) after conversion therapy, confirmed by pathology. Assessed by multidisciplinary team (MDT) discussion.

    Measured: Up to 12 months

  2. Progression-Free Survival (PFS)

    Time from randomization to first documented disease progression (per RECIST 1.1 by BICR) or death from any cause, whichever occurs first.

    Measured: Up to 12 months

  3. Disease Control Rate

    Percentage of participants achieving CR, PR, or stable disease (SD) as best overall response per RECIST 1.1 (BICR).

    Measured: Up to 12 months

  4. Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Incidence and severity of all AEs and SAEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Includes FMT-related infections and gastrointestinal events.

    Measured: From first dose through 30 days after last dose (up to 12 months)

  5. Relative Dose Intensity (RDI) of Standard Therapy

    Proportion of planned dose of standard first-line therapy actually delivered (calculated as actual dose / planned dose × 100). Compares treatment compliance between arms.

    Measured: Up to 12 months

  6. Patient-Reported Outcomes (PROs) - Hospital Anxiety and Depression Scale (HADS)

    Change from baseline in anxiety and depression scores assessed by HADS questionnaire.

    Measured: Baseline, every 8 weeks during treatment, and end of treatment (up to 12 months)

  7. Patient-Reported Outcomes (PROs) - EORTC QLQ-C30

    Change from baseline in global health status, functional scales, and symptom scales (fatigue, nausea/vomiting, pain, etc.) assessed by EORTC QLQ-C30 questionnaire.

    Measured: Baseline, every 8 weeks during treatment, and end of treatment (up to 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07509398
Sponsor's protocol ID
FMT-CRC-2026-001
Status last verified
Mar 2026
First submitted
29 Mar 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes. De-identified individual participant data (IPD) that underlie the primary and key secondary outcomes of this trial will be made available to qualified external researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator. Data will be available beginning 12 months after publication of the primary study results and ending 5 years after publication. Access will require approval of a formal data sharing request and a signed data use agreement.

Publications

  • Chen YC, Chuang CH, Miao ZF, Yip KL, Liu CJ, Li LH, Wu DC, Cheng TL, Lin CY, Wang JY. Gut microbiota composition in chemotherapy and targeted therapy of patients with metastatic colorectal cancer. Front Oncol. 2022 Sep 23;12:955313. doi: 10.3389/fonc.2022.955313. eCollection 2022.

    PubMed 36212420

  • Zhao W, Lei J, Ke S, Chen Y, Xiao J, Tang Z, Wang L, Ren Y, Alnaggar M, Qiu H, Shi W, Yin L, Chen Y. Fecal microbiota transplantation plus tislelizumab and fruquintinib in refractory microsatellite stable metastatic colorectal cancer: an open-label, single-arm, phase II trial (RENMIN-215). EClinicalMedicine. 2023 Nov 14;66:102315. doi: 10.1016/j.eclinm.2023.102315. eCollection 2023 Dec.

    PubMed 38024475

  • Yang Y, An Y, Dong Y, Chu Q, Wei J, Wang B, Cao H. Fecal microbiota transplantation: no longer cinderella in tumour immunotherapy. EBioMedicine. 2024 Feb;100:104967. doi: 10.1016/j.ebiom.2024.104967. Epub 2024 Jan 18.

    PubMed 38241975

  • Gu C, Sha G, Zeng B, Cao H, Cao Y, Tang D. Therapeutic potential of fecal microbiota transplantation in colorectal cancer based on gut microbiota regulation: from pathogenesis to efficacy. Ther Adv Gastroenterol. 2025 Mar 18;18:17562848251327167. doi: 10.1177/17562848251327167. eCollection 2025.

    PubMed 40104324

  • Kim Y, Kim G, Kim S, Cho B, Kim SY, Do EJ, Bae DJ, Kim S, Kweon MN, Song JS, Park SH, Hwang SW, Kim MN, Kim Y, Min K, Kim SH, Adams MD, Lee C, Park H, Park SR. Fecal microbiota transplantation improves anti-PD-1 inhibitor efficacy in unresectable or metastatic solid cancers refractory to anti-PD-1 inhibitor. Cell Host Microbe. 2024 Aug 14;32(8):1380-1393.e9. doi: 10.1016/j.chom.2024.06.010. Epub 2024 Jul 25.

    PubMed 39059396

  • Duttagupta S, Messaoudene M, Hunter S, Desilets A, Jamal R, Mihalcioiu C, Belkaid W, Marcoux N, Fidelle M, Suissa D, Ponce M, Geiger M, Malo J, Piccinno G, Puncochar M, Filin A, Heidrich V, Rusu D, Mbaye B, Durand S, Ben Aissa I, Puller V, de Lahondes R, Blais N, Tehfe M, Owen S, Belanger K, Parvathy SN, Shieh B, Raphael J, Lenehan J, Breadner D, Rothenstein J, Rozza N, Maillou J, Nili S, Prifti DK, Pinto F, Armanini F, Kim-Schulze S, Marron TU, Kroemer G, Derosa L, Zitvogel L, Silverman M, Segata N, Maleki Vareki S, Routy B, Elkrief A. Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. Nat Med. 2026 Apr;32(4):1337-1350. doi: 10.1038/s41591-025-04186-5. Epub 2026 Jan 28.

    PubMed 41606121

  • Fernandes R, Jabbarizadeh B, Rajeh A, Hong MMY, Baines KJ, Ernst S, Winquist E, Ali AS, Penny S, Figueredo R, Parvathy SN, Lenehan JG, Pinto DM, Silverman MS, Maleki Vareki S. Fecal microbiota transplantation plus immunotherapy in metastatic renal cell carcinoma: the phase 1 PERFORM trial. Nat Med. 2026 Apr;32(4):1325-1336. doi: 10.1038/s41591-025-04183-8. Epub 2026 Jan 28.

    PubMed 41606120

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Standard First-Line Therapy and FMT Combined with Standard First-Line Therapy in people with Unresectable Colorectal Cancer and Colorectal Cancer (Locally Advanced or Metastatic), run by Shanghai 10th People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiyi Chen (+86 15896453859, qiyichen2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 12 months (from randomization to best overall response assessment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07509398, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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