NL-OMON47572已完成2 期
A prospective, multicentre, randomised, controlled study evaluating SIR-Spheres® Y-90 resin microspheres preceding standard cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic CholangioCArcinoma. - SIRCCA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •a) Willing, able and mentally competent to provide written informed consent
- •b) Aged 18 years or older
- •c) Histologically or cytologically confirmed unresectable and/or non ablatable
- •intrahepatic cholangiocarcinoma
- •d) Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patients
- •are permitted to have loco-regional lymph node involvement defined as: portal
- •LN * 2 cm and/or para aortic LN * 1.5 cm in longest diameter, and/or up to 2
- •indeterminate lung lesions < 1 cm if these lung lesions are PET negative.
- •e) Chemotherapy naïve. Adjuvant chemotherapy is not permitted
- •f) ECOG performance status 0 or 1,
- •g) Adequate haematological function defined as:
- •Haemoglobin * 10g/dL
- •WBC * 3.0 x 109/L
- •Absolute neutrophil count (ANC) * 1.5 x 109/L
- •Platelet count * 100,000/mm3,
- •h) Adequate liver function defined as:
- •Total bilirubin * 30 *mol/L (1.75 mg/dL)
- •Albumin * 30 g/L
- •i) Adequate renal function defined as:
- •Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
- •Creatinine clearance * 45 ml/min (calculated with Cockcroft-Gault Equation)
- •All blood test results must be within 14 days prior to randomisation.
- •j) Life expectancy of at least 3 months without any active treatment
- •k) Female patients must either be postmenopausal, sterile (surgically or
- •radiation- or chemically-induced), or if sexually active use an acceptable
- •method of contraception during the study.
- •l) Male patients must be surgically sterile or if sexually active must use an
- •acceptable method of contraception during the study.
- •m) Considered suitable to receive either treatment regimen in the clinical
- •judgement of the treating investigator.
排除标准
- •a) Patients with only non-measurable lesions in the liver according to RECIST
- •b) Incomplete recovery from previous liver surgery, e.g. unresolved biliary
- •tree obstruction or biliary sepsis or inadequate liver function
- •c) Biliary stenting in situ
- •d) Main trunk Portal Vein Thrombosis (PVT)
- •e) Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of
- •ascites detected at imaging is acceptable.)
- •f) Mixed HCC-ICC disease.
- •g) History of prior malignancy. Exceptions include in-situ carcinoma of the
- •cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous
- •cell carcinomas of the skin, recurrent intra-hepatic cholangiocarcinoma post
- •local treatment, or any early stage (stage I) malignancy adequately resected
- •with curative intent at least 5 years prior to study entry
- •h) Suspicion of any bone metastasis/metastases or central nervous system
- •metastasis/metastases on clinical or imaging examination.
- •i) Prior internal or external radiation delivered to the liver.
- •j) Pregnancy; breast feeding,
- •k) Participation within 28 days prior to randomisation, in an active part of
- •another clinical study that would compromise any of the endpoints of this study.
- •l) Evidence of ongoing active infection that may affect treatment feasibility
- •m) Prior Whipple*s procedure
研究者
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