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

Phase 1

Active, not recruiting

• Conditions: Unresectable Hepatocellular Carcinoma
• Interventions: Drug: Donafenib Tosilate Tablets; Biological: Toripalimab Injection

• Registration Number: NCT04605185
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Study Start: 2021-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Donafenib/JS001/TACE	Donafenib Tosilate Tablets	Donafenib and JS001 Combined With TACE
Donafenib/JS001/TACE	Toripalimab Injection	Donafenib and JS001 Combined With TACE

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity(DLT)	21 days after the first dose of JS001 and Donafenib, assessed up to 2 years	Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.	defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death
Overall survival (OS)	From the date of randomization until death due to any cause, assessed up to 2 years.	The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.
Progression free survival (PFS)	From date of randomization until the date of objective disease progression or death, assessed up to 2 years.	The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China