The purpose of this study is to evaluate the safety and efficacy of the combination of donafenib and TACE in the perioperative period of liver transplantation.
This study plans to enroll about 20 patients with hepatocellular carcinoma (HCC) who do not meet the UCSF standard, they will receive donafenib combined with TACE in downstaging period and donafenib only in adjuvant period. Before the liver transplantation, the safety and efficacy will be evaluated every 3 and 6 weeks, respectively, until liver transplantation or the disease progression that couldn't be treated by TACE. After transplantation, the safety and efficacy will be evaluated every 6 and 12 weeks, respectively, until intolerable toxicity, recurrence or up to 12 months treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Beijing Tsinghua Changgung Hospital
Beijing, China
RECRUITINGDownstaging success rate
Definition of successful downstaging: those who meet the UCSF standard with baseline AFP \> 1000 ng/ml need to be reduced to \< 500 ng/ml.
Time frame: Immediately after downstaging treatment
Objective response rate before transplantation (ORR)
Time frame: 1 year
Complete pathological response rate (pCR)
Time frame: 1 year
Recurrence-free survival (RFS)
Including median RFS, 1, 2, 3-years RFS rate
Time frame: 3 years
Overall survival (OS)
Including median OS, 1, 2, 3-years OS rate
Time frame: 3 years
Adverse events
Time frame: 3 years
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