CalliSpheres Drug-Eluting Beads With Oxaliplatin to Treat Inoperable NET Liver Metastases: A Multi-center Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease control rate (DCR) of intrahepatic lesions
研究概览
简要总结
A prospective clinical trial to study the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in treating patients who have inoperable neuroendocrine neoplasm (NEN) liver metastases.
详细描述
OBJECTIVES:
I. Determine the safety and effectiveness of Transcatheter Artery Chemotherapy and Embolization (TACE) using CalliSpheres Drug-Eluting Beads with oxaliplatin (DEBOXA) in patients with inoperable neuroendocrine neoplasm (NEN) liver metastases.
II. Determine the response rate (RR) of intrahepatic lesions in patients treated with this regimen.
III. Determine the overall survival (OS), progression-free survival time (DFS), time to hepatic progression (THP), and quality of life (QOL) in patients treated with this regimen.
IV. Safety assessment: adverse events (AEs) and severe adverse events(SAEs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis is confirmed by biopsy or clinical data, primary site is resected or primary site is not resected but without risks of bleeding, obstruction in the near future.
- •Failure of ≥ 1 system treatment, such as long-acting somatostatin or EP chemotherapy regimen.
- •Standard surgical resection can not be performed because of extent liver involvement （liver involvement ≥ 2 lobes or ≥ 2 major vessels）, or patients who are not willing to accept surgical operation.
- •Predicted survival >3 months.
- •Child Pugh Score: ≤ 7
- •ECOG score for performance status: 0-1
- •Informed consensus is achieved.
排除标准
- •Metastases to other organs or sites besides liver.
- •Prior TACE for liver tumors in 1 year.
- •Obvious hepatic arterio-venous shunt or arterio-portal shunt.
- •Prior or concurrent malignancy (Except basal carcinoma or squamous carcinoma of skin or carcinoma in situ of cervex uteri which has been cured).
- •Platelet count < 50,000/mm^3 or white blood cell count <3,000 /mm^3 without hypersplenism.
- •Creatinine greater than upper limit of normal (ULN)
- •AST or AST > 5 times ULN
- •Compromised coagulation: INR (International normalised ratio) >1.5, current anti-coagulation therapy or hemorrhagic disorders.
- •History of severe diseases involving heart, kidney, marrow, lung or central neural system.
- •Infection diseases which need antibiotics treatment before less than 1 month.
- •Co-existing morbidity or social environment which may lead patients not to obey study protocol or threat patients' safety.
研究组 & 干预措施
D-TACE
D-TACE for inoperable NEN liver metastases. Embolization agent: CalliSpheres Drug-Eluting Beads Chemotherapy agent: Oxaliplatin
干预措施: D-TACE (Drug)
结局指标
主要结局
Disease control rate (DCR) of intrahepatic lesions
时间窗: 2 years
Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced CT or MRI scan according to RECIST criteria.
次要结局
- Progression Free Survival (PFS)(30 months)
- Quality of life (QOL)(30 months)
- Side effects and adverse events(30 months)
- Overall survival (OS)(30 month)