2024-519322-20-00招募中3 期
CAPRI-3 Phase 3 clinical study to evaluate the use of continuing cetuximab treatment beyond first line progression in molecular selected metastatic colorectal cancer patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 41
- 主要终点
- The Overall Response Rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator.
研究概览
简要总结
To investigate the efficacy in terms of Objective Response Rate (ORR) of chemotherapy doublet plus cetuximab as second line treatment in molecular selected wild type metastatic colorectal cancer patients compared to chemotherapy doublet plus bevacizumab. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically proven diagnosis of colorectal adenocarcinoma.
- •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.
- •Signed informed consent obtained before screening.
- •Diagnosis of metastatic disease.
- •Efficacy of a first line therapy containing anti-EGFR drug with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or a prolonged (at least 6 months) stable disease.
- •Progression to first line therapy.
- •RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis.
- •RAS (NRAS and KRAS exon 2,3 and 4), BRAFV600E, PIK3CA, EGFR ECD wild-type and HER2 not amplified in liquid biopsy at the time of screening (according to NGS, Foundation/Roche).
- •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.
排除标准
- •Any contraindication to the use of cetuximab, bevacizumab, Irinotecan, 5-FU, oxaliplatin, folic acid.
- •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 diarrhea.
- •Severe, non-healing wounds, ulcers or bone fractures
- •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.
- •Absent or restricted legal capacity.
- •Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease.
- •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
The Overall Response Rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator.
The Overall Response Rate (ORR) according to RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator.
次要结局
- Progression Free Survival (PFS) according to RECIST 1.1 defined as the time from random assignment in the clinical trial to disease progression or death from any cause.
- The Overall Survival (OS) defined as the interval from enrollment to death for every cause.
- The safety profile of the trial drugs as measured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS.
研究者
Fortunato Ciardiello
Scientific
Gruppo Oncologico Dell'Italia Meridionale
研究点 (41)
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