Status:
UNKNOWN
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an open, multi-center phase I/II clinical study.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04503902
Start Date
October 15 2020
End Date
December 1 2023
Last Update
November 29 2022
Active Locations (1)
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1
No.81 Hospital of PLA
Nanjing, Jiangsu, China, 215006