A Single-arm, Open-label, Phase Ⅱ Clinical Trial of Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer
The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.
⁃ 1\. Patients who have fully understood and voluntarily signed informed consent forms for this study, have good compliance, and cooperate with follow-up; 2. Age ≥ 18 years and ≤ 75 years old; 3. ECOG 0-1; 4. Expected survival time ≥ 12 weeks; 5. Patients confirmed by histology or pathology to have colon or rectal glands; 6. Primary or metastatic tumors of the colon are identified as RAS/BRAF wild-type; 7. PET/CT scan, CT scan, MRI or intraoperative exploration diagnosis (if applicable during resection of primary colorectal tumor), record evidence of limited liver metastasis in the patient (histological confirmation of liver metastasis is not required); 8. Primary colorectal cancer can be or has been radically resected, initial inability to R0 resection of liver metastases, or residual liver volume ≤ 30-40% after resection; 9. The patient has at least one measurable liver metastasis lesion (according to RECIST 1.1 standard); 10. There was no previous liver metastasis chemotherapy; 11. The main organ function is normal, which meets the following criteria:
• Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):
• A. Hemoglobin (Hb) ≥ 90 g/L; B. Neutrophil count (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 100 × 109/L;
• Biochemical examination must meet the following standards:
• A. Total bilirubin (TBIL)\<1.5 upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 2.5 ULN, while for patients with liver metastasis, they are less than 5 ULN; C. Serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance rate\>60ml/min (Cockcroft Gault formula); D. The urine routine test results show that urine protein (UPRO)\<2+or 24-hour urine protein quantification\<1g;
• Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);
• Coagulation function: International standardized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN;
• Pulmonary function: First second forced expiratory volume (FEV1) ≥ 1.2 L, FEV1% ≥ 50%, carbon monoxide diffusion volume (DLCO) ≥ 50%;
• Other: lipase ≤ 1.5 × ULN (if lipase\>1.5) × ULN can be included if there is no clinical or imaging confirmation of pancreatitis; Amylase ≤ 1.5 × ULN (if amylase\>1.5 × ULN can be included if there is no clinical or imaging confirmation of pancreatitis; Alkaline phosphatase (ALP) ≤ 2.5ULN.
• Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period;