Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Clinical Study of Toripalimab（JS001） Combined With Donafenib in Patients With Advanced Hepatocellular Carcinoma

This study is an open, multi-center phase I/II clinical study.

It will explore the tolerability (phase I) and effectiveness (phase II) of the Donafenib tosilate tablets combined with Toripalimab injection in patients with advanced HCC. The study is conducted in two phases, the first phase is the dose exploration phase (phase I), and the second phase is the dose expansion phase (phase II).

Inclusion Criteria:

• Patients with locally advanced or metastatic HCC who are not suitable for surgical resection, who are clinically diagnosed or confirmed by histopathology and/or cytology according to the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2017);
• At least one measurable lesion (according to RECIST v1.1);
• ECOG performance status score of 0 or 1;
• Life expectancy ≥ 12 weeks；
• Have not received systemic therapy (systemic chemotherapy and/or molecular targeted therapy).If the patient has received adjuvant chemotherapy after local treatment, the chemotherapy needs to be over for more than 12 months, and disease progression or metastasis occurs；
• Fully understand this research and voluntarily sign the ICF。

Exclusion Criteria:

• Patients with diffuse liver cancer, hepatic encephalopathy that is difficult to control, and liver cancer patients whose lesion size accounts for 70% or more of the entire liver.
• Patients with intrahepatic cholangiocarcinoma (ICC) or HCC-ICC mixed type；
• Tumor invades inferior vena cava VP4.