Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Progression -free survival at 6 months (from date of inclusion)
研究概览
简要总结
Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated.
RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres.
In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.
Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.
详细描述
Extended description of the protocol, including information not already contained in other fields, such as comparison studied.
It is a pilot study including 20 patients with unresectable intra-hepatic CCK in tumor progression after first-line therapy.
Description of the protocol :
- Information and signed CONSENTMENT
- Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
- Therapeutic phase : intra-arterial administration of resin-based microspheres ( SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease is bi-lobar.
- Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable intra-hepatic CCK histologically proven
- •Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy
- •Performance status < 2 ; 4) Bilirubin < 36 micromol/l
- •age > 18 years
排除标准
- •Extra-hepatic metastases
- •Uncontrolled biliary obstruction
- •Contra-indications to RE.
结局指标
主要结局
Progression -free survival at 6 months (from date of inclusion)
时间窗: 6 months
Progression -free survival defined by the number of patients alive at 6 months without tumor progression documented on imaging evaluation ( MRI or CT) using RECIST criteria version 1.1.
次要结局
- Tumor response at 1 month, 2 months, 4 months, 6 months(1 month, 2 months, 4 months, 6 months)
- Overall Survival at 6 months(6 months)
- Safety of RADIOEMBOLIZATION using the NCI-CTCAE V3.0 classification.(2 weeks, 1 month, 2 months, 4 months, 6 months)