EUCTR2017-003509-16-IT进行中（未招募）1 期
Serum cytokine levels as predictors of the efficacy of aflibercept in combination with FOLFIRI in metastatic Colo-Rectal Cancer patients (mCRC) - FLIBER
FONDAZIONE RICERCA TRASLAZIONALE (FORT)0 个研究点目标入组 124 人开始时间: 2022年1月20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
- 124
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. Adult age (>= 18 years old);
- •2. An Eastern Cooperative Oncology Group (ECOG);
- •performance status (PS) of 0 or 1;
- •3. Histologically or cytologically proven colorectal
- •adenocarcinoma with metastatic disease not menable to potentially curative treatment;
- •4. Measurable disease according to the RECIST criteria 1.1;
- •5. Documented progression while on or after completion of a single prior oxaliplatin-containing regimen in patients treated in the neoadjuvant and metastatic setting; documented relapsing disease within 6 months of completion of oxaliplatinbased regimen in patients treated in the adjuvant setting;
- •6. Aflibercept in combination with irinotecan planned as per standard clinical practice and decision by the treating oncologist;
- •7. Any adverse events from prior anticancer therapy must have recovered to grade = 1 ([NCI-CTCAE] version 5.0) before study enrolment;
- •8. Patients were to have adequate bone marrow, liver and renal: alanine transaminase (ALT) = 3 × institutional upper limit of normal (ULN) [= 5 × ULN in presence of liver metastases], total bilirubin = 1.5 × institutional ULN [= 2.0 x ULN in presence of liver metastases], neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L, proteinuria ¿ 1+ on the dipstick, creatinine = 2.5 x institutional ULN or creatinine clearance of =40 mL/min;
- •9. Signed written consent form;
- •10. Patients of reproductive potential, must use adequate contraception methods;
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •1. Radiation therapy or any previous anti-neoplastic systemic treatment within the past 28 days before study enrollment;
- •2. History of major surgery within 28 days before study enrollment; 3. Known prior malignancies or known brain metastases ( patients with adequately treated basal cell or squamous cell skin cancer,
- •carcinoma in situ of the cervix, or any other cancer from which the patient had been disease-free for more than 10 years are permitted);
- •4. Severe acute or chronic medical condition that may impair the ability to participate in the study or may interfere with the interpretation of results;
- •5. Any contraindication to the administration of aflibercept, irinotecan, 5-fluorouracil or folinic acid;
- •6. History of any auto-immune or rheumatic disease; any active bacterial or viral infection;
- •7. History of uncontrolled hypertension and diabetes within 3 months before enrollment;
- •8. History of daily use of corticosteroids or immune-suppressive medications;
- •9. Deep vein thrombosis within 4 weeks before treatment;
- •10. Pregnant and breast-feeding women;
- •11. Patients of reproductive potential who refuse to use effective methods of contraception;
研究者
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