sirt followed by cis-gem chemotherapy versus cis-gem chemotherapy alone as 1st line treatment of patients with unresectable intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the study planned to evaluate the benefit of applying selective internal radiation therapy (sirt) using sir-spheres y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or cis-gem) in patients with unresectable intrahepatic cholangiocarcinoma. half of the patients were randomized to cis-gem chemotherapy plus sirt, and half of the patients were randomized to cis-gem alone.

this clinical study was a prospective, multicenter, randomized, controlled study evaluating sir-spheres y-90 resin microspheres followed by cisplatin-gemcitabine (cis-gem) chemotherapy vs. cis-gem chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma. randomized patients were to be followed until death, withdrawal of consent, or until end of study.

Eligibility criteria:
inclusion criteria: * willing, able and mentally competent to provide written informed consent. * aged 18 years or older. * histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma. * liver-only or liver predominant intrahepatic cholangiocarcinoma. patient are permitted to have loco-regional lymph node involvement defined as: portal ln \</= to 2 cm and/or para aortic ln \</= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions \< 1 cm if these lung lesions are positron emission tomography (pet) negative. * chemotherapy naïve. adjuvant chemotherapy is not permitted. * eastern cooperative oncology group (ecog) performance status 0 or 1. * adequate hematological function defined as: hemoglobin \>/= 10g/dl white blood cell count (wbc) \>/= 3.0 x 10\^9/l absolute neutrophil count (anc) \>/= 1.5 x 10\^9/l platelet count \>/= 100,000/mm\^3 - adequate liver function defined as: total bilirubin \ /= 30 g/l - adequate renal function defined as: serum urea and serum creatinine \ /= 45 ml/min (calculated with cockcroft-gault equation) * life expectancy of at least 3 months without any active treatment * 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. * male patients must be surgically sterile or if sexually active must use an acceptable method of contraception during the study. * considered suitable to receive either regimen in the clinical judgement of the treating investigator. exclusion criteria: * patients with only non-measurable lesions in the liver according to recist criteria * incomplete recovery from previous liver surgery, e.g. unresolved biliary tree obstruction or biliary sepsis or inadequate liver function * biliary stent in situ * main trunk portal vein thrombosis (pvt) * ascites, even if controlled with diuretics. (a minor peri-hepatic rim of ascites detected at imaging is acceptable). * mixed hepatocellular carcinoma - intrahepatic cholangiocarcinoma (hcc-icc) disease * 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 1) malignancy adequately resected with curative intent at least 5 years prior to study entry * suspicion of any bone metastasis/metastases or central nervous system metastasis/metastases on clinical or imaging examination. * prior internal or external radiation delivered to the liver. * pregnancy; breast feeding. * participation within 28 days prior to randomization, in an active part of another clinical study that would compromise any of the endpoints of the study. * evidence of ongoing active infection that may affect treatment feasibility or outcome. * prior whipple's procedure.