Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study.
(1) Advanced or metastatic intrahepatic cholangiocarcinoma confirmed by histopathology that cannot be surgically removed.
(1) Histology includes components of mixed hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or biliary adenocarcinoma.
Parallel
radiotherapy
RadiationRadiotherapy
FOLFIRI or FOLFOX or Regorafenib
DrugFOLFIRI or FOLFOX or Regorafenib
PFS
PFS is will be measured from the randomization to progression or death from any cause. Progression includes enlargement of target lesions and development of new distant metastases and will be assessed using RECIST 1.1.
OS
OS will be the time from randomization until death from any cause.
LCR
Local control of all metastases (refers to all lesions present at time of randomization) will be measured from date of randomization until progression of target lesions.
AEs
Toxicity will involve treatment-related toxicity, including early and late toxicity, as assessed using Common Terminology Criteria for Adverse Events v5.0. All adverse events occurring from randomization until 3 months after the end of treatment, regardless of relatedness to study medication, will be recorded as acute toxicities. Adverse events considered relevant and occurring later than 3 months after the end of treatment will be recorded as late toxicities.
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