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

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04605185
• Other study ID #: JS001D-C-103
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Donafenib Tosilate Tablets
100mg Qd/150mg Qd/100mg Bid, po

Biological:
• Toripalimab Injection
240 mg, iv drip,q3w

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity(DLT)	Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.	21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
Secondary	Overall survival (OS)	The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.	From the date of randomization until death due to any cause, assessed up to 2 years.
Secondary	Progression free survival (PFS)	The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death	From date of randomization until the date of objective disease progression or death, assessed up to 2 years.
Secondary	Duration of response (DOR)	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	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.