Combination of Regorafenib and Nivolumab in Unresectable Hepatocellular Carcinoma

Sponsor
Asan Medical Center
Study ID
NCT04310709
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular
  • Hepatoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Regorafenib and nivolumab are proven effective agents for the management of unresectable hepatocellular carcinoma patients. As preclinical studies have suggested potential synergism between antiangiogenic agents and immune checkpoint inhibitors, regorafenib and nivolumab may have synergism in terms of efficacy. Herein, this study investigates the combination of regorafenib and nivolumab as first-line therapy in patients with unresectable hepatocellular carcinoma.

Key Dates

Start date
Jun 16, 2020
Status verified
Dec 2022
Primary completion
May 30, 2022
Completion
Nov 30, 2022

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: REGONIVO
    Nivolumab - 480 mg IV on Day 1, every 4 weeks Regorafenib \- 80 mg per oral once daily for 21 consecutive days starting on Day 1, every 4 weeks.

Primary Outcome Measure

Response rate [ Time Frame: 6 months ]

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