Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Zelgen Biopharmaceuticals

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Advanced Hepatocellular Carcinoma

Treatments

Drug: Donafenib Tosilate Tablets

Drug: Toripalimab Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04503902

JS001D-C-102

Details and patient eligibility

About

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

Full 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 two phases, the first phase is the dose exploration phase (phase I), and the second phase is the dose expansion phase (phase II).

Enrollment

46 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.