Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

Korábbi kezelés

• Patients who have previously received BRAF inhibitors or irinotecan liposomes;

Más betegség

• Proven allergic to the test drug and/or its excipients;
• Acute or subacute intestinal obstruction or chronic inflammatory bowel disease;
• have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer;

Életkor

• Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures;

Egyéb

• symptomatic, untreated brain metastases or meningeal metastases that fail to achieve clinical stability;
• Patients considered by the investigator to be unsuitable for this study.

• at least 18 years of age;
• Colorectal adenocarcinoma was confirmed by histological or cytopathological examination, and RAS wild /BRAF V600E mutation was detected by PCR or NGS;
• Failure or intolerance of standard first-line treatment. First-line regimens including oxaliplatin and/or irinotecan in combination with fluorouracil in patients with MSS; For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required;
• At least one measurable lesion according to RECIST v1.1;
• ECOG score is 0~2;
• Good bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault);
• Expected survival ≥3 months;
• Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this study and sign informed consent.