EUCTR2010-020188-19-DK进行中（未招募）不适用
Intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine and in patients with a KRAS-wild type tumour in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma. A phase II trial.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Inclusion criteria
- •Informed consent
- •Age > 18 years
- •Performance status 0-1; expected survival = 3 months
- •Patient with histologically or cytologically adenocacinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with choloangiocarcinoma
- •Liver metastases not suitable for surgery or other local treatment
- •Extrahepatic disease should be excluded by PET-CT-scan.
- •Prior treatment with chemotherapy or no progression on first line treatment
- •Metastases < 70 % of the liver
- •Neutrofile granulocytes ? 1.5 x 109/l og thrombocytes ? 100 x 109/l
- •Bilirubine ? 2.0 x UNL (upper normal limit).
- •Creatinine-clearence ? 30 ml/min.
- •INR < 2.
- •Intrahepatic treatment can be accomplished
- •The patients is approved by a multidisciplinary team
- •The treatment is approved by ”Second Opinion udvalget”
- •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
- •Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
- •Cytotoxic or experimental treatment within a 14 days period before start of trial medication
- •The patient is not allowed to participate in other clinical trials.
- •Any clinical symptoms suggesting peripheral neuropathy grade 2
- •Other severe medical conditions
- •Severe cardial disease or AMI < 1 year
- •Presence of diseases preventing oral therapy
- •Patients with uncontrolled infection
- •Pregnant or lactating women
- •Women capable of childbearing not using a sufficient method of birth control
- •Patients not able to understand the treatment or to collaborate
- •Prior serious or unsuspected reaction after treatment with fluorpyrimidin
- •Known prior hypersensitivity reactions to the agents
- •Interstitial pneumonitis or pulmonary fibrosis
研究者
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Intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer.A phase II trial in patients with limited extrahepatic disease.EUCTR2009-014821-17-DKHerlev Hospital100
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