EUCTR2011-001364-22-IT进行中（未招募）1 期
A multi-center, open-label clinical trial to evaluate the objective response rate of bevacizumab in combination with modified FOLFOX-6 followed by one year of maintenance with bevacizumab alone in patients with initially not or borderline resectable colorectal liver metastases (The CLMO-001 Trial)
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
- ROCHE
- 入组人数
- 77
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. Male or female patients aged > 18 years 2. Histologically confirmed adenocarcinoma of the colon or rectum 3. In case of primitive rectal tumor, all patients with metachronous metastases or with synchronous metastases can be enrolled, if the primitive lesion is at a distance > 10 cm from the anal margin 4. Presence of metastatic disease confined to the liver 5. ECOG Performance Status 0 - 1 6. No previous chemotherapy for metastatic disesase or use of VEGF or EGFR targeting agents in any treatment line. 7. Adequate bone marrow and liver function (ANC > 1500, PLT > 100.000/mm3, Hb>9 gr/dl, bilirubin level either normal or < 1.5 xULN, ALT and AST < 5x ULN) 8. Adequate renal function: serum creatinine level < 1.5x ULN 9. Urine analysis with proteinuria < 2+ 10. Male and female patients with reproductive potential must use at least one approved contraceptive method 11. Patients able and willing to give written informed consent. Consent must be obtained prior to any study-specific procedure 12. Surgical criteria for hepatic resection: A patient may be included if the answer to at least one of the following statements is ''yes'': 1. Unresectable patients, for whom the 2 following conditions of resectability are not satisfied: • Preservation of 2 contiguous segments maintaining both vascularization (inflow and outflow) and biliary drainage • Maintenance of at least 30% of the total hepatic parenchyma 2. Borderline resectable patients, in whom the surgeon suspects not to obtain a R0 surgery (for example, patients with hepatic metastases in sites where the lesion, to be removed with the criteria above mentioned, risks a R1 resection) 3. Resectable patients, but high risk”, defined as follows: • If the patient has a metachronous disease: he must have > 3 metastases • If the patient has a synchronous disease: he must have 1 metastatic lesion = 5 cm or multiple lesions (= 2) of any size.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1. Presence of extrahepatic metastatic disease (except for peduncolar limphonodes involvement) 2. Evidence of lomboaortic and celiac lymphonodes involvement 3. Radiotherapy to any site within 4 weeks before the study 4. History of inflammatory bowel disease and/or acute/subacute bowel occlusion 5. Presence of serious non-healing wound or ulcer 6. Evidence of bleeding diathesis or coagulopathy 7. Uncontrolled hypertension 8. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 9. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes 10. Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration (which cannot be discontinued 5 days before enrollment or 8 days before, in case of long-acting FANS, like piroxicam) 11. Treatment with any investigational drug within 30 days prior to enrollment. 12. Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications 13. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. 14. 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 . Endoscopic biopsy performed within 14 days. 15. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential 16. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications. 17. Patients with known infection with HIV, HBV, HCV. Testing is not required in the absence of clinical signs and symptoms suggestive of these conditions. 18. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol and follow-up procedures.
研究者
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