Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

NCT ID: NCT04503902

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2023-12-31

Brief Summary

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

Detailed 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).

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS001+Donafenib

Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv

Group Type: EXPERIMENTAL

Donafenib Tosilate Tablets

Intervention Type: DRUG

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

Intervention Type: DRUG

JS001 will be administrated by intravenous (i.v.) infusion once every 21 days

Interventions

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.

Intervention Type: DRUG

Toripalimab Injection

JS001 will be administrated by intravenous (i.v.) infusion once every 21 days

Intervention Type: DRUG

Other Intervention Names

Donafenib; JS001

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shukui Qin, PhD

Role: PRINCIPAL_INVESTIGATOR

No.81 Hospital of PLA

Locations

No.81 Hospital of PLA

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shukui Qin, PhD

Role: CONTACT

qinsk@csco.org.cn

+86-025-80864541

Facility Contacts

Shukui Qin

Role: primary

qinsk@csco.org.cn

+86-025-80864541

Other Identifiers

JS001D-C-102

Identifier Type: -

Identifier Source: org_study_id