NCT05048017

Regorafenib Combined With PD-1 Inhibitor Therapy for Second-line Treatment of Hepatocellular Carcinoma

Regorafenib Combined With PD-1 Inhibitor Therapy for Second-line Treatment of Hepatocellular Carcinoma: A Single Arm, Nonrandomized, Single Center Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, nonrandomized, single center clinical study to investigate the safety and efficacy of regorafenib combined with PD-1 inhibitor therapy for second-line treatment of hepatocellular carcinoma

Detailed description

To observe and evaluate the efficacy, safety and biomarker analysis of regorafenib combined with PD-1 inhibitor for the second-line treatment of hepatocellular carcinoma.In this study, 20 patients with hepatocellular carcinoma will be enrolled for regorafenib combined with PD-1 inhibitor therapy.In the absence of any of the following conditions, such as withdrawal of informed consent by subjects, intolerable drug side effects, or the investigator's determination that further study is not appropriate, the expected study treatment for each subject will continue until radiologically confirmed tumor progression. Efficacy indicators and safety indicators will be observed during the trial.

Conditions

• Hepatocellular Carcinoma
• Regorafenib
• PD-1 Inhibitor

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib, 120 mg, once a day, 3 weeks on/1 week off
DRUG	PD-1 inhibitor	Camrelizumab: 200mg (BW ≥ 50 kg) or 3 mg/kg (BW \< 50 kg) Toripalimab: 240mg is given through intravenous drip every 3 weeks on Day 1 of each course of treatment. Pembrolizumab: 200mg is given through intravenous drip every 3 weeks.

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2021-09-17
• Last updated: 2023-03-29

Locations

1 site across 1 country: China