Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Criteria

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.