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
The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colon 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 colon cancer patients with liver metastasis.
• Histological or cytological confirmed advanced colon cancer with liver metastasis.
• Signed written informed consent.
• Have not received anti-tumor treatment.
• According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
• Patients of both sexes, aged ≥18 years and ≤75 years.
• ECOG PS 0-1;
• Expected survival time ≥ 3 months;
• 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.