Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer

Inclusion criteria

• . . Hematological Parameters: A complete blood count must indicate hemoglobin levels of ≥90 g/L (with no blood transfusions administered within the preceding 14 days), an absolute neutrophil count of ≥1.5 × 10⁹/L, and a platelet count of ≥100 × 10⁹/L.
• . . Liver Function: Liver function tests should reveal alanine aminotransferase (ALT) levels ≤2.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) levels ≤2.5 × ULN, total bilirubin levels ≤1.5 × ULN, and albumin levels ≥30 g/L. In cases where liver metastases are present, ALT and AST levels may be elevated to ≤5 × ULN, while total bilirubin must remain ≤1.5 × ULN.
• . . Renal Function: Renal function should be assessed with serum creatinine levels ≤1.5 × ULN or a creatinine clearance, calculated using the Cockcroft-Gault formula, of \>60 mL/min.
• . . Cardiac Function: Cardiac assessment via echocardiography should indicate a left ventricular ejection fraction (LVEF) of ≥55%. Additionally, the corrected QT interval (QTcF) on electrocardiogram should be ≤480 ms, with creatine kinase (CK) levels ≤1 × ULN and troponin or high-sensitivity troponin levels ≤1 × ULN.
• . . Coagulation Function: Coagulation parameters must include an international normalized ratio (INR) of ≤1.5 × ULN and activated partial thromboplastin time (APTT) of ≤1.5 × ULN.
• . . Urinalysis: Urinalysis should demonstrate urine protein levels of \<2+. If urine protein levels are ≥2+, a 24-hour urine protein quantification test is required. Patients with quantitative urine protein levels \<1 g/24 h are considered eligible, while those with levels ≥1 g/24 h are ineligible. Furthermore, patients exhibiting urine protein levels ≥2+ who have not undergone quantitative testing are also excluded.

Exclusion criteria