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Clinical Trials in China / NCT06801665
Recruiting Phase 2

FMT+ QL1706+Bevacizumab+ XELOX as First-line Treatment for Advanced MSS-type Colorectal Cancer With Liver Metastasis

NCT06801665 · tracked via the Priya Life Science China tracker
Sponsor
Hua Jiang
Phase
Phase 2
Started
2025-04-17
Last updated
2026-09-10

Condition(s) studied

Colorectal Cancer Liver Metastasis

Investigational drug(s) / intervention(s)

FMT+QL1706+Bevacizumab+XELOX

FMT+QL1706+Bevacizumab+XELOX: Participants will receive FMT combined with QL1706+Bevacizumab+XELOX for 6 cycles. If there is no progression of the disease after 6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. The therapy of maintenance treatment stage was at the discretion of the investigator.

Study summary

The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colorectal cancer patients with liver metastasis who have not received prior treatment. This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with QL1706+Bevacizumab+XELOX to enhance the anti-tumor immune effect at the same time, thereby improving the prognosis of colorectal cancer patients with liver metastasis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Second People's Hospital of Changzhou Changzhou China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801665 on ClinicalTrials.gov ↗ ← All trials in China