Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma Clinical Trial

— HCC  

Official title:

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Clinical Study of Toripalimab（JS001） Combined With Donafenib in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503902
• Other study ID #: JS001D-C-102
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 15, 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Shukui Qin, PhD
• Phone: +86-025-80864541
• Email: qinsk[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Donafenib Tosilate Tablets
In the dose exploration phase (phase I),three doses of Donafenib tosylate tablets [100 mg once a day (QD); 100 mg twice a day (BID); 200 mg, BID] will be explored. In the dose expansion phase (phase II), patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.
• Toripalimab Injection
JS001 will be administrated by intravenous (i.v.) infusion once every 21 days

Locations

Country	Name	City	State
China	No.81 Hospital of PLA	Nanjing	Jiangsu

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)	Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial	28 days after the first dose of JS001 and Donafenib
Primary	Objective response rate(ORR) as determined by the Invertigator using RECIST V1.1	The ratio of patients who are evaluated as CR or PR	From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
Secondary	Anti-JS001 antibody		From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
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 time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
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 the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months