Donafenib Plus Sintilimab for Advanced HCC

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Criteria

Inclusion Criteria:

• Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically

• Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included

• Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included

• At least one measurable lesion

• Child-Pugh score ≤7

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ and hematologic function

• Life expectancy of at least 3 months

Exclusion Criteria:

• Diffuse HCC

• Macrovascular invasion involving the main trunk or inferior vena cava

• Central nervous system metastasis

• History of malignancy other than HCC

• Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment

• Uncontrolled ascites

• History of hepatic encephalopathy

• Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC

• History of organ and cell transplantation

• Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab

• Autoimmune disease or immune deficiency

• Severe organ (heart, kidney) dysfunction