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

Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

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.

The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).

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.