NCT04611165

Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced HCC

A Phase II Study of Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced Hepatocellular Carcinoma Who Have Vascular Invasion With or Without Sorafenib-Experience in an HBV-endemic Area

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRT

Detailed description

\<Treatment phase\> Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. External beam radiotherapy begins 2-7 days after the first dose of nivolumab. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent or study closure. \<Follow-Up phase \> After the treatment phase, subjects will undergo follow up for survival every 12 weeks (± 7 days) from the last dose or the use of other anticancer treatments and/or therapies, and the survival follow up will be performed for at least 18 months after the enrollment of the last subject. The patient will be followed for survival follow up and the use of other anticancer treatments and/or therapies. Based on the assumed dropout rate of 12%, a total of 50 subjects need to perform the study (50=44/(1-0.12))

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	* Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. * EBRT begins 2-7 days after the first dose of nivolumab. * The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.

Timeline

• Start date: 2019-11-15
• Primary completion: 2022-12-30
• Completion: 2023-12-15
• First posted: 2020-11-02
• Last updated: 2025-05-22

Locations

1 site across 1 country: South Korea