EUCTR2007-000175-42-IT进行中（未招募）不适用
A double-blind, randomised, multicenter, phase III study ofbevacizumab in combination with capecitabine and cisplatinversus placebo in combination with capecitabine and cisplatin, asfirst-line therapy in patients with advanced gastric cancer. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 760
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. Written informed consent obtained prior to any study specific procedures.
- •2. Age ≥ 18 years
- •3. ECOG PS of 0, 1 or 2
- •4. Life expectancy of at least 3 months
- •5. Able to comply with the protocol
- •6. Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction* with
- •inoperable, locally advanced or metastatic disease, not amenable to curative therapy.
- •*Adenocarcinoma of gastro-oesophageal junction (GOJ) is defined as tumours that have their centre within 5 cm proximal and distal of the anatomical cardia as described in Siewert?s
- •classification system.
- •7. Measurable disease or non-measurable but evaluable disease, according to the Response
- •Evaluation Criteria in Solid Tumours (RECIST). Patients with peritoneal disease would generally
- •be regarded as having evaluable disease and allowed to enter the trial.
- •8. Patient not receiving anticoagulant medication must have an INR ≤ 1.5 and aPTT ≤ 1.5 x ULN
- •within 7 days prior to randomisation.*
- •*The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is
- •within therapeutic limits (according to the medical standard in the institution) and the patient has
- •been on a stable dose of anticoagulants for at least two weeks at the time of randomisation.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous chemotherapy for locally advanced or metastatic gastric cancer. Patients may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6
- •months prior to randomisation.
- •2. Previous platinum or anti-angiogenic therapy (i.e. anti-VEGF or VEGFR tyrosine kinase inhibitor
- •3. Patients with locally advanced disease who are candidates for curative therapy (including
- •operation and/or chemotherapy and/or radiotherapy).
- •4. Radiotherapy within 28 days of randomisation. Patients given palliative radiotherapy to peripheral
- •sites (e.g. bone metastasis) may enter the study before 28 days have elapsed but must have recovered from any acute, reversible effects.
- •5. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomisation,
- •or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery).
- •6. Minor surgical procedures within 2 days prior to randomisation (including CVAD placement for chemotherapy administration).
- •7. Evidence of CNS metastasis at baseline. A CT or MRI scan within 28 days prior to randomisation
- •is mandatory to exclude CNS involvement in case of clinical suspicion of CNS metastasis.
- •8. History or evidence upon physical/neurological examination of CNS disease unrelated to cancer
- •unless adequately treated with standard medical therapy, e.g. uncontrolled seizures.
- •9. History of another malignancy which could affect compliance with the protocol or interpretation
- •of results. Patients are generally eligible if they have had non-melanomatous cancer of the skin,
- •carcinoma in situ of the cervix, or another malignancy treated with curative intent if they have
- •been disease-free for more than 5 years.
- •10. Inadequate bone marrow function: ANC < 1.5 x 109/L, platelet count < 100 x 109/L or Hb < 9 g/dL.
- •11. Inadequate liver function: serum (total) bilirubin > 1.5 x ULN, AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases), alkaline phosphatase > 2.5 x ULN or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases.
- •12. Inadequate renal function:
- •Creatinine clearance should be ≥ 60 mL/min. The Cockroft and Gault formula is recommended for calculation of creatinine clearance. Patients with a creatinine clearance just below 60 ml/min may be eligible if a measured creatinine clearance (based on 24 hour urine collection or other reliable method) is ≥ 60 mL/min.
- •Urine dipstick for proteinuria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.
- •13. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically
- •significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (≤ 6 months
- •prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment.
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