30
Participants
Start Date
December 4, 2021
Primary Completion Date
October 28, 2022
Study Completion Date
August 31, 2023
Donafenib+sintilimab
"Part 1 (Safety Run-in): donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-days cycle.~Part 2: donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.~Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity."
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou
Second Affiliated Hospital of Guangzhou Medical University
OTHER