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Colorectal Neoplasms MalignantPhase 2NCT05279677

FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of CRC Patients With Advanced Stage

A Phase 2 study testing Fecal microbiota transplantation plus Sintilimab and Fruquintinib in people with Colorectal Neoplasms Malignant, run by Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A single-arm, phase II study was designed to evaluate the efficacy and safety of fecal microbiota transplantation plus Sintilimab and Fruquintinib as the later line treatment in colorectal patients with advanced stages. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Neoplasms Malignant
What is being tested?
Fecal microbiota transplantation plus Sintilimab and Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
12 Aug 2022to Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Sign the informed consent form.
  • Metastatic or locally advanced colorectal adenocarcinoma unresectable or unfit for radical radiochemotherapy confirmed by pathology or cytology.
  • Microsatellite stable or pMMR patients failed standard treatment, including platinum, irinotecan, fluorouracil and Bevacizumab (Ras and BRAF wt patients should recived Cetuximab).
  • Patients have at least one lesion could be evaluated by RECIST v1.1 or mRECIST.
  • The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1.
  • The life expectancy is more than 3 months.
  • Good organ function:
  • Blood routine: hemoglobin ≥90g/L, white blood cell ≥3.0×10^9/L, neutrophil ≥1.5×10^9/L, platelet ≥100×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥60ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis.

Who cannot join

  • Have received any anti-PD-1, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies and other immunotherapy in the past.
  • Have received any TKI therapy in the past.
  • Clinically significant ascites.
  • Known to have allergic reactions to any ingredients or excipients of experimental drugs.
  • Have received any antibiotics within 28 days before the first medication or any probiotics or prebiotics within 14 days before the first medication.
  • Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy).
Show all 16Show fewer
  • Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment.
  • Brain metastasis or meningeal metastasis has been confirmed. Patients with neurological symptoms should receive brain CT / MRI examination to exclude metastasis.
  • Patients who is suffering from intestinal obstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia, renal failure, liver failure or cerebrovascular disease.
  • Diabetes was not controlled, defined as HbA1c > 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure > 140 / 90 mmHg after antihypertensive drug.
  • Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months.
  • Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C.
  • Suffering from autoimmune diseases or history of organ transplantation requiring immunosuppressive therapy.
  • May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results.
  • Pregnant women (determined by serum human chorionic gonadotropin [hCG]) or lactating women, or plan to conceive during the treatment period, 2 months after cetuximab treatment and 6 months after capecitabine treatment. Women of childbearing age with positive or no pregnancy test at baseline. Women of childbearing age or sexually active men were not willing to use contraception during the study period, at least 2 months after cetuximab treatment and 6 months after capecitabine treatment. Postmenopausal women must be amenorrhea for at least 12 months to be considered infertile.
  • There are other serious diseases that the researchers believe patients cannot be included in the study

Trial locations and contacts

1 site in 1 country.

Aiping Zhou, MD contact

86 13691161998

zhouap1825@126.com

China1 site, 1 recruiting

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

    Aiping Zhou, MD, +86 13691161998, zhouap1825@126.com

    Recruiting

Other trials in China

About this study

Official title: Phase II, Single-arm Study of FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of Colorectal Cancer Patients With Advanced Stage

A single-arm, phase II study was designed to evaluate the efficacy and safety of fecal microbiota transplantation plus Sintilimab and Fruquintinib as the later line treatment in colorectal patients with advanced stages.

Read the detailed description

The combination of regorafenib plus nivolumab had already presented a manageable safety profile and encouraging antitumor activity in patients with mCRC as the REGONIVO trail reported. While additional investigations showed limited ORRs between 7%-33% as third or later line treatement in mCRC. Gut microbiota modulation, with the aim to reverse established microbial dysbiosis, is a novel strategy for the treatment of CRC. The individualized gut microbiome transplantation may further imrpove the efficacy of the combination therapy of CPI and TKI. Thus, a single-arm, phase II study was designed to evaluate the efficacy and safety of FMT plus Sintilimab and Fruquintinib as the later line treatment in CRC patients with advanced stages.

Being tested
Fecal microbiota transplantation plus Sintilimab and Fruquintinib
Keywords
Gastrointestinal Microbiome
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • Fecal microbiota transplantation plus Sintilimab and FruquintinibDrug

    Microbiota capsules containing 1g gut microbiota, po d1-3 before anti-tumor treatment, total for 8 cycles.

    Sintilimab 200mg iv, q3w. Fruquintinib 5mg po d1-14, q3w.

Study groups in NCT05279677
Study groupRoleWhat they receive
FMTExperimentalFecal microbiota transplantation plus Sintilimab and Fruquintinib
Receives: Drug: Fecal microbiota transplantation plus Sintilimab and Fruquintinib

What is being measured

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

  1. ORR

    Objective Response Rate

    Measured: Up to 2 years

Secondary outcomes (3)

  1. OS

    Overall Survival

    Measured: Up to 2 years

  2. PFS

    Progression Free Survival

    Measured: Up to 2 years

  3. Adverse events

    Safety and tolerance

    Measured: Up to 2 years

Timeline

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

  1. First posted15 Mar 2022
  2. Study start12 Aug 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionApr 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279677
Sponsor's protocol ID
NCC3157
Status last verified
Mar 2022
First submitted
5 Mar 2022
Last updated
23 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal microbiota transplantation plus Sintilimab and Fruquintinib in people with Colorectal Neoplasms Malignant, run by Chinese Academy of Medical Sciences at 1 site in China.

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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Aiping Zhou, MD (86 13691161998, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 2 years). 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 NCT05279677.

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 23 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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