Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study

non-operable hepatocellular carcinoma

The objective response rate, defined as the best overall response occurring within 6 months’ post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma, The best overall responses at months 1, 3, and every 3 months until 24 months after radioembolization, Time to liver progression (TTLP), defined as the time from patient inclusion to progression according modified RECIST criteria, Progression-free survival (PFS), defined as the time from patient inclusion to progression according mRECIST criteria (whatever the location of the progressive lesion) including death from any cause and initiation of a new antineoplastic therapy, Overall survival (OS), defined as the time from patient inclusion to death from any cause, The biological response rate is defined as the proportion of patients with a complete or partial AFP response, as determined by the lowest serum alpha-fetoprotein (AFP) level observed during the first six months. A complete AFP response is defined as normalization of the AFP level at a minimum of one-point measurement. A partial AFP response is defined as no normalization of the AFP level, but a reduction of at least 20% from the baseline level. Point measurements are planned at M1, M3, and M6

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