EUCTR2020-005078-82-IT进行中（未招募）1 期
Phase III study in mCRC patients with RAS/BRAF wild type tissue and RAS mutated in LIquid BIopsy to compare in first-line therapy FOLFIRI plus CetuximAb or BevacizumAb - LIBImAb
AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA0 个研究点目标入组 280 人开始时间: 2021年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of written informed consent;
- •2. Male or female > 18 years of age;
- •3. Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis);
- •4. Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- •5. Patient with left colorectal cancer;
- •6. Patients suitable for first line chemotherapy;
- •7. Life expectancy > 3 months;
- •8. At least one site of measurable disease per RECIST criteria ver. 1.1;
- •9. ECOG Performance status = 2;
- •10. Adequate bone marrow, liver and renal function assessed before starting study treatment;
- •11. If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown;
- •12.Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study treatment.
- •For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.
- •13. Subjects and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male subjects with female partners of WOCBP after the last trial treatment. Male
- •subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to
- •use adequate contraception as approved by the investigator (barriers contraceptive measure or oral contraception).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1. Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before
- •the randomization;
- •2. Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid;
- •3. Radiotherapy to any site within 4 weeks before the randomization;
- •4. Serious, non-healing wound, ulcer, or bone fracture;
- •5. Evidence of bleeding diathesis or coagulopathy;
- •6. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy;
- •7. Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
- •skin, or in situ cervical cancer that has undergone potentially curative therapy;
- •8. Active and untreated brain (CNS) metastases and/or carcinomatous meningitis;
- •9. Active infection requiring systemic therapy or active disseminated intravascular coagulation;
- •10. History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antobodies);
- •11. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection;
- •12. Chronic, daily treatment with high-dose aspirin (>325 mg/day);
- •13. Any previous venous thromboembolism > NCI CTCAE Grade 3;
- •14. History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first
- •study treatment. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea;
- •15. Current, recent (within 10 days prior to study treatment start) or ongoing treatment with anticoagulants for therapeutic
- •16.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or
- •anticipation of the need for major surgical procedure during the course of the study;
- •17. History of any severe hypersensitivity reactions to any monoclonal antibody;
- •18. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient’s participation in the
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