Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Criteria

Inclusion Criteria:

• Age 18-75 (inclusive), male or female;

• Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment of primary liver cancer" (2019 Edition);

• At least one measurable lesion (according to RECIST v1.1)

• ECOG performance status score of 0 -1;

• Life expectancy ≥ 12 weeks;

• Fully understand this research and voluntarily sign the ICF.

Exclusion Criteria:

• Diffuse liver cancer；

• Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；

• Pregnancy or lactation；

• Patients with extrahepatic diffusion；

• Spontaneous tumor rupture；

• Expected non-compliance.