Poop pills plus chemo: new combo tackles tough colon cancer
NCT ID NCT06801665
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether transplanting healthy gut bacteria (fecal microbiota transplant) can boost the effects of immunotherapy and chemotherapy in 30 people with advanced colon cancer that has spread to the liver. Participants receive the combination for six cycles, then may continue with maintenance therapy. The main goal is to see how many patients' tumors shrink significantly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fecal microbiota transplant (FMT) plus QL1706 (an immunotherapy), bevacizumab, and XELOX chemotherapy
- What this could lead to
- If it works, this could improve tumor shrinkage and delay cancer progression in people with advanced colon cancer that has spread to the liver.
- What could go wrong
- This is a small, early-phase trial with only 30 participants and no comparison group, so results may not apply broadly. Combining multiple treatments also raises the risk of serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histological or cytological confirmed advanced colorectal cancer with liver metastasis. 2. Signed written informed consent. 3. Have not received anti-tumor treatment. 4. According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1. 5. Patients of both sexes, aged ≥18 years and ≤75 years. 6. ECOG PS 0-1; 7. Expected survival time ≥ 3 months; 8. Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements, as follows: 1\) Blood routine: ANC ≥ 1.5 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, HGB ≥100 g/L (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: TBIL ≤1.5 x ULN; ALT/AST ≤ 5 x ULN; ALP ≤5×ULN; 3) Renal function: Cr ≤1.5×ULN, or creatinine clearance ≥50 mL/min: Urine routine results showed urinary protein \< 2+; 4) Coagulation function: INR or PT ≤1.5 x ULN. 9.For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration. 10\. For women of childbearing potential (WOCBP): agreement to refrain from heterosexual intercourse or use contraception. 11\. For men: agreement to refrain from heterosexual intercourse or use a condom, and agreement to refrain from donating sperm. Exclusion Criteria: 1. Suffered from other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid carcinoma. 2. Patients requiring elective surgery during the trial. 3. Patients who cannot take oral drugs, or have conditions that the investigator determines to significantly affect gastrointestinal absorption, such as chronic diarrhea, intestinal obstruction, etc., and are not suitable for treatment. 4. Patients during pregnancy (positive pregnancy test) or lactation. 5. Central nervous system metastasis or meningeal metastasis. 6. Uncontrollable bone metastasis, or patients at risk of fracture, requiring surgery, local radiation therapy. 7. Patients with active infection requiring systemic anti-infection treatment. 8. Patients with a history of immunodeficiency, including those who are positive for HIV antibody tests. 9. Patients with known, active autoimmune diseases. 10. Patients with uncontrolled active hepatitis B, patients with hepatitis C virus infection (HCV antibody positive). 11. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe arrhythmia, acute coronary syndrome within 6 months, congestive heart failure, aortic dissection, stroke, and T IA history. 12. Severe bleeding events occur within half a year, or high bleeding risk factors such as active digestive tract ulcers and esophageal and gastric varices due to liver cirrhosis. 13. Patients with diabetes who cannot be stably controlled by drugs (including insulin). 14. Mental or language disorders that prevent communication with the patient; 15. Patients participating in another clinical trial. 16. MSI-H/ d MMR without immunotherapy; left colorectum of Ras, Raf wild-type. 17. The investigator believes that the subject has other serious systemic diseases or other conditions that make him unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second People's Hospital of Changzhou
RECRUITINGChangzhou, China
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