Donafenib Plus Sintilimab for Advanced HCC

Hepatocellular Carcinoma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT05162352
• Study type: Interventional
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Mingyue Cai, Dr.
• Phone: +86-20-34156205
• Email: cai020@yeah.net
• Status: Recruiting
• Phase: Phase 2
• Start date: December 4, 2021
• Completion date: May 2023