The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus half-dose donafenib (a kind of anti-angiogenesis agents) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus half-dose donafenib (a kind of anti-angiogenesis agents) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension. Subjects who meet the admission criteria will be treated with half-dose donafenib after TIPS until disease progression, intolerable toxicity, death, withdrawal of the patient, or the researchers determined that the drug must be discontinued. The primary outcome measure is to evaluate the objective response rate (ORR) based on mRECIST. The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), the recurrence rate of portal hypertension-related haemorrhage or ascites, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Perform transjugular intrahepatic portosystemic shunt under the guidance of DSA
Half-dose donafenib, 100mg BID P.O. unless any evidence of disease progression or unacceptable side effects.
Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR) by RECIST 1.1 and mRECIST
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 or mRECIST
Time frame: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to 1 year)
Overall survival (OS)
OS is measured from the start date of the TIPS until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier, assessed up to 2 years.
Time frame: From the start date of the TIPS until date of death from any cause, assessed up to 2 years.
Progression-free survival (PFS)
The progression-free survival (PFS) defined as the time from the date of TIPS to the date of first documented progression (mRECIST or RECIST v1.1) or date of death from any cause, whichever came first, assessed up to 2 years
Time frame: The progression-free survival (PFS) defined as the time from the date of TIPS to the date of first documented progression (mRECIST or RECIST v1.1) or date of death from any cause, whichever came first, assessed up to 2 years
Disease control rate (DCR)
DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 or mRECIST.
Time frame: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to 1 year)
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Rate of portosystemic shunt stent patency
The status of the shunt stent evaluated by the color Doppler ultrasound.
Time frame: 1, 3, 6, 9, 12 months after TIPS
Recurrence rate of portal hypertension-related complications
It was defined as the percentage of patients with recurrent gastrointestinal bleeding, refractory ascites, hepatic pleural effusion, and portal hypertensive gastroenteropathy within 6 months after TIPS
Time frame: From date of TIPS until portal hypertension-related complications (up to 6 months)