A Single-center Phase II Clinical Study of Irinotecan Liposome (II)-Based Combination Regimen as a Treatment for Irinotecan-Resistant Colorectal Cancer.
Phase II clinical study of irinotecan liposome (II)-based combination regimen as a treatment for irinotecan-resistant colorectal cancer.
• Patients agree and have signed an informed consent form and are willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other trial procedures;
• age: 18 years and older, male or female;
• patients with pathologically confirmed advanced colorectal cancer(excluding all other histological types);
• Patients with colorectal cancer who have received ≥ second-line systemic antitumor therapy (including chemotherapy with irinotecan regimen, targeted therapy, etc.);
• There is at least one unidimensionally measurable lesion according to the evaluation standard of solid tumor curative effect (RECIST 1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• expected survival ≥ 3 months;
• Normal function of major organs. Laboratory tests were to meet the following requirements: hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no corrective treatment used within 14 days); neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L) (no growth factors used within 14 days); white blood cell count (WBC) ≥ 3.0 × 109/L(no corrective treatment used within 14 days);platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L) (no corrective treatment used within 14 days) ; total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 3 times the upper limit of normal (ULN), and ≤ 5 × ULN for patients with liver metastases; Serum Cr ≤ 1.5 times ULN, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula);Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); international normalized ratio INR ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN;
• Patients with potential fertility need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 6 months after the end of study treatment; and must have a negative serum HCG test within 7 days before study enrollment; and must be non-lactating. Male participants in this study consent to the utilisation of contraceptive measures for the duration of the study period, in addition to a six-month period subsequent to the study's conclusion.