Clinical Study of Second-line Treatment of Patients with Advanced Colorectal Cancer with Irinotecan Liposome (II), Fluorouracil in Combination with Bevacizumab or Cetuximab
Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.
• Provide written informed consent to voluntarily enroll in this study.
• Men or women aged 18-75 years.
• Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
• Patients who have failed one prior systemic therapy.
• Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
• Life expectancy of at least 3 months.
• Measurable lesions at baseline as assessed by the investigator by imaging (according to RECIST 1.1), measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred).
• Function of vital organs in accordance with the following requirements (no medication with any blood component, cell growth factor corrective therapy is allowed within 14 days prior to the first administration of study drug); Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L; Haemoglobin ≥ 9 g/dL; Serum albumin ≥ 2.5 g/dL; Total bilirubin ≤ 1.5 × upper limit of normal; alanine aminotransferase, aspartate aminotransferase≤ 2.5 × upper limit of normal, and if liver metastases are present, alanine aminotransferase, aspartate aminotransferase ≤ 5 × upper limit of normal Serum creatinine ≤ 1.5 × upper limit of normal or creatinine clearance \> 60 mL/min (Cockcroft-Gault); Activated partial thromboplastin time (APTT) and International Normalised Ratio (INR) ≤ 1.5 × upper limit of normal (screened for use of stable doses of anticoagulant therapy such as low molecular heparin or warfarin where the INR is within the expected therapeutic range of the anticoagulant).
• Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiation of trial drug administration and use effective contraception (e.g., intrauterine device, birth control pills, or condoms) during the trial period and for at least 3 months after the last dose of trial drug; for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for at least 3 months after the last dose of trial drug. For male subjects whose partners are women of childbearing potential