EUCTR2010-020385-13-SE进行中（未招募）不适用
Randomized phase II trial of combination chemotherapy with panitumumab or bevacizumab for patients with inoperable cholangiocarcinoma without KRAS mutations. - GOC-B-P
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
- 78
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
- •Histologically verified adenocarcinoma arisen from gallbladder, extra-or intrahepatic bilde ducts or malignant cells consistent with the above and simultaneous radiological findings consistent with cholangiocarcinoma
- •- minimum 18 yeras of age
- •-curative treatment currently not an option(operatic, stereotactic radiation or similar
- •- KRAS analyzed and found wild type(wt)
- •-performance status 0-2
- •-evaluable disease according to RECIST
- •-Adequate hematology, liverfunctions tests and blood chemistry as outlined in the protocol
- •-fertile women must present a negative pregnancy test
- •-all fertile patients must use adequate anticonception methods, during and for 6 months after completing the trial
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Other malignant disease within 5 years prior to enrolment except form non-melanotic skin cancer and carcinoma in situ cervicis uteri
- •Interstitial pneumonitis or subsequent pulmonary fibrosis
- •Pregnant or breastfeeding women
- •Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
- •Significant non-healing wound or ulcers
- •Active haemorrhage or increased risk of haemorrhage (e.g. tumor invasion in large vessels or known øsofagusvaricer)
- •Known hypersensitivity to panitumumab, bevacizumab or any of the auxilliary agents
- •Grade IV fistulas
- •Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilised hypertension >160/100
- •Haemoptysis > 2.5 ml within 2 weeks prior to enrolment
- •Previous serious and unexpected reactions or know hypersensitivity to one or more of the applied cytostatics.
- •Previous cytostatic treatment of inoperable cholangiocarcinoma
- •Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
- •Other concomitant experimental treatment
- •Severe medical disease such as considerable heart disease, serious active infection or other diease making the patient unfit for study participation as assessed by investigator
- •Other malignant disease within 5 years prior to enrolment except form non-melanotic skin cancer and carcinoma in situ cervicis uteri
- •Interstitial pneumonitis or subsequent pulmonary fibrosis
- •Pregnant or breastfeeding women
- •Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
- •Significant non-healing wounds or ulcers
- •Active haemorrhage or increased risk of haemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
- •Known hypersensitivity to panitumumab, bevacizumab or any of the auxilliary agents
- •Grade IV fistulas
- •Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilised hypertension >160/100
- •Haemoptysis > 2.5 ml within 2 weeks prior to enrolment
- •Previous serious and unexpected reactions or known hypersensitivity to one or more of the applied cytostatics.
研究者
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