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

Zelgen Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Unresectable Hepatocellular Carcinoma

Treatments: Drug: Donafenib Tosilate Tablets; Biological: Toripalimab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04605185

JS001D-C-103

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Donafenib/JS001/TACE

Experimental group

Description:

Donafenib and JS001 Combined With TACE

Treatment:

Biological: Toripalimab Injection

Drug: Donafenib Tosilate Tablets