ACTRN12624000288527尚未招募3 期
Efficacy of intraperitoneal bevacizumab for decreasing or delaying re-accumulation of recurrent malignant ascites in chemotherapy resistant solid tumours: a randomised trial (REZOLV3R)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients with symptomatic, cytologically confirmed malignant ascites:
- •a. who have any solid organ malignancy excluding pancreatic cancer
- •b. who are either not receiving or not planned to receive additional systemic anticancer treatment for the duration of study treatment
- •c. that has recurred following at least one therapeutic ascitic drainage within 28 days prior to study registration
- •d. who require therapeutic paracentesis for symptomatic management
- •2. Age: 18 years and over
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •4. Estimated survival of 12 weeks or more
- •5. Study treatment both planned and able to start within 14 days of registration
- •6. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments
- •7. Signed, written informed consent.
排除标准
- •1. At high risk of bowel perforation, including but not limited to any one or more of the following:
- •a. History of bowel obstruction within 6 months prior to study entry
- •b. CT scan that demonstrates involvement of bowel by tumour
- •c. Symptoms to suggest impending bowel obstruction
- •d. Prior whole abdominal radiotherapy
- •2. Active or non-healing intra-abdominal fistulae or history of fistulae within previous 60 days
- •3. Major surgery within the preceding 6 weeks
- •4. Pulmonary emboli or deep vein thrombosis unless on anticoagulation and no thrombotic episode in the preceding 6 weeks
- •5. Known bleeding diathesis, or history of active bleeding including known gastric ulceration within 60 days
- •6. Uncontrolled hypertension, or unstable cardiac disease
- •7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- •9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
- •10. Previous episode of ascites due to non-malignant causes, for example hepatic failure, portal venous obstruction
- •11. Known hypersensitivity to or serious reaction resulting from any components of bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised antibodies
- •12. Have received anti-VEGF therapy within the last 4 weeks.
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