Fecal transplant plus QL1706, bevacizumab, and XELOX as first-line treatment for advanced MSS colon cancer with liver metastases

Fecal Microbiota Transplantation Combined With QL1706, Bevacizumab, and XELOX as First-line Treatment for Advanced MSS-type Colon Cancer With Liver Metastasis: A Prospective, Multi-center, Single-arm Phase II Study

This trial will test whether giving a fecal microbiota transplant before combined QL1706, bevacizumab, and XELOX chemotherapy helps adults with untreated advanced MSS colon cancer that has spread to the liver.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changzhou No.2 People's Hospital (other)
• Drugs / interventions: immunotherapy, radiation, Bevacizumab, chemotherapy
• Locations: 1 site (Changzhou)
• Trial ID: NCT06801665 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multicenter phase II trial planning to enroll about 30 patients with newly diagnosed, previously untreated advanced colon cancer with liver metastases. Participants receive a fecal microbiota transplant two days before starting combination therapy with QL1706, bevacizumab, and XELOX given every three weeks for six cycles, with maintenance therapy afterward at the investigator's discretion. Tumor response is measured by RECIST v1.1 every six weeks and safety is monitored with NCI-CTCAE v5.0 every three weeks, with adverse events followed for 90 days after treatment. Blood and stool samples are collected at baseline, after two and four cycles, and before maintenance to explore biomarkers related to treatment response.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed, previously untreated advanced colon cancer with liver metastases, ECOG 0–1, adequate organ function, and MSS (not MSI‑H/dMMR).

Not a fit: Patients with MSI‑H/dMMR tumors, prior anti‑tumor therapy, poor performance status, or inadequate organ or bone marrow function are unlikely to be eligible or to benefit from this regimen.

Why it matters

Potential benefit: If successful, this approach could improve response rates and survival by reshaping the gut microbiome to boost anti-tumor immunity alongside chemotherapy and targeted therapy.

How similar studies have performed: Early studies combining FMT with immune checkpoint inhibitors in other cancers have shown encouraging signals, but combining FMT with QL1706 plus bevacizumab and XELOX in MSS colon cancer is largely novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Histological or cytological confirmed advanced colon 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.

Where this trial is running

Changzhou

• The Second People's Hospital of Changzhou — Changzhou, China (RECRUITING)

Study contacts

• Study coordinator: Hua Jiang MD

Conditions: Colon Cancer Liver Metastases