Spots Global Cancer Trial Database for Donafenib Plus Sintilimab for Advanced HCC

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Trial Identification

Brief Title: Donafenib Plus Sintilimab for Advanced HCC

Official Title: Donafenib Combined With Sintilimab for Advanced HCC: a Single-arm, Single-center, Prospective Study

Study ID: NCT05162352

Conditions

Hepatocellular Carcinoma

Interventions

Donafenib+sintilimab

Study Description

Brief Summary: This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).

Detailed Description: This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC. 30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer \[BCLC\] stage C, or China liver cancer staging \[CNLC\] IIIa/IIIb) will be enrolled in the study. Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle. Part 2: patients will receive 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.