Donafenib Plus Sintilimab for Advanced HCC

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 4, 2021

Primary Completion Date

October 28, 2022

Study Completion Date

August 31, 2023

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

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."

Trial Locations (1)

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

All Listed Sponsors
lead

Second Affiliated Hospital of Guangzhou Medical University

OTHER

NCT05162352 - Donafenib Plus Sintilimab for Advanced HCC | Biotech Hunter | Biotech Hunter