NCT04503902

Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Toripalimab Injection	JS001 will be administrated by intravenous (i.v.) infusion once every 21 days

Timeline

• Start date: 2020-10-15
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-08-07
• Last updated: 2022-11-29

Locations

1 site across 1 country: China