2024-518534-81-00招募中2 期
Investigate the efficacy and safety of a bio-marker driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wt tumors at start of first line.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRC.
研究概览
简要总结
To investigate the efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in patients with RAS/BRAF wild type (WT) mCRC at start of first line therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of colorectal adenocarcinoma
- •Signed informed consent obtained before screening.
- •Diagnosis of metastatic disease
- •RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1)
- •Male or female patients ≥ 18 years of age
- •ECOG Performance Status 0,1
- •Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:Bone marrow: • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L • Hemoglobin (Hgb) ≥ 9 g/dL • Platelets ≥ 100 x 109/L Liver function: • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN Renal function: • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
- •If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment
- •If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate
排除标准
- •Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid,bevacizumab, trifluridine-tipiracil, regorafenib
- •Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- •Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
- •Known or clinically suspected brain metastases
- •History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
- •Severe, non-healing wounds, ulcers or bone fractures
- •Uncontrolled hypertension
- •Marked proteinuria (nephrotic syndrome)
- •Known DPD deficiency (specific screening not required)
- •Known history of alcohol or drug abuse
- •A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
- •Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease
- •Absent or restricted legal capacity
- •Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix
- •Pregnancy (exclusion to be ascertained by a beta hCG test)
- •Breastfeeding
- •Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception•
- •Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)
- •Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
- •Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
结局指标
主要结局
Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRC.
Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRC.
次要结局
- Progression Free Survival (PFS): measured from the start of therapy until the first observation of disease progression or death due to any cause.
- Overall Survival (OS): calculated from the start of the study treatment until death.
- Safety: Adverse events graded according NCI CTCAE v 5.0.
- Molecular profiles of tumor tissue and liquid biopsy: molecular analysis of formalin fixed paraffin embedded (FFPE) tumor tissue, which is representative of the primary tumor or of a metastatic site at the diagnosis of mCRC, will be performed before the first line, whilst blood samples for liquid biopsy will be collected before each line of treatment.
研究者
Fortunato Ciardiello
Scientific
Gruppo Oncologico Dell'Italia Meridionale
研究点 (24)
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