NCT04718909

Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC

Regorafenib Combined With Sintilimab Versus Regorafenib Alone as the Second-line Treatment for Unresectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for patients with unresectable hepatocellullar carcinoma (HCC).

Detailed description

This is an open-label, multicenter, randomized controlled trial to evaluate the efficacy and safety of regorafenib plus sintilimab compared with regorafenib alone as the second-line treatment for unresectable HCC. 180 patients with unresectable HCC who progress after sorafenib or lenvatinib treatment or are intolerant to these drugs will be enrolled in the study. The Patients will be treated with regorafenib plus sintilimab or regorafenib alone using an 1:1 randomization scheme. Regorafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. The administration of regorafenib will be delayed in cases of severe toxicities. And after recovery, regorafenib will be reintroduced at a reduced dose according to the dose delay and reduction guidelines. Treatment of sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the arm of regorafenib plus sintilimab, patients will be allowed to have regorafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
DRUG	Regorafenib + sintilimab	Regorafenib: 160 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off). Sintilimab: 200mg i.v. q3w.
DRUG	Regorafenib	160 mg p.o. qd for 3 weeks of every 4 week cycle.

Timeline

• Start date: 2021-01-09
• Primary completion: 2023-07-08
• Completion: 2023-12-31
• First posted: 2021-01-22
• Last updated: 2022-11-10

Locations

1 site across 1 country: China