Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes：a Phase II Single-arm Study

Fujian Cancer Hospital0 个研究点目标入组 33 人开始时间: 2024年11月1日最近更新: 2024年7月8日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Fujian Cancer Hospital
入组人数: 33
主要终点: Objective Response Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18-75 years (including 18 and 75 years);
•ECOG PS 0 or 1;
•Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;
•Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;
•At least one measurable lesion as defined in RECIST version 1.1;
•Fertile patients must be willing to take highly effective pregnancy avoidance measures during the study period and ≥120 days after the last dosing; Female patients with negative urine or serum pregnancy test results within ≤7 days before the first administration of the study drug;
•Have fully understood the study and voluntarily signed the informed consent.
•Adequate organ and bone marrow function, meeting the following definitions:
•Blood routine (no transfusion, no use of granulocyte colony stimulating factor [G-CSF], no use of other drugs for correction within 14 days before treatment); Absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥9.0 g/dL; Platelet count (PLT) ≥80×109/L;
•Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min; Serum albumin ≥2.8g/dL. Patients with poor nutritional status before neoadjuvant therapy could also be enrolled if they met the criteria through parenteral nutrition. Total bilirubin (TBIL) ≤ 1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;

排除标准

•Pregnant or lactating women;
•Patients with a known history of allergy to any investigative drug, similar drug, or excipient;
•Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
•Patients with a history of thromboembolism, except thrombosis caused by PICC;
•There are patients with active infection;
•Patients with difficult to control hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg);
•Patients with brain metastases with clinical symptoms or imaging evidence;
•Treatment contraindications exist in combination with other chronic diseases;
•Patients with previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis and other conditions, and the current AE is still ≥ grade 2;
•According to NCI CTCAE version 5.0 evaluation criteria, existing patients with various toxic and side effects caused by previous treatment ≥ grade 2;
•Other conditions that the investigator determined were not suitable for inclusion in the study.
•Received any anti-tumor therapy and participated in other clinical studies within 4 weeks before enrollment.