To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.
Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
240mg intravenously every 3 weeks
Radiotherapy dose was 36 \~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression free survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on iRECIST, or date of death, whichever occurred first
Time frame: 6 months
Overall survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Time frame: 6 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on iRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Time frame: 6 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 6 months
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