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

Sponsor
National Cancer Center, Korea
Study ID
NCT04611165
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nivolumab — DRUG
    * 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.

Study Details

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

Key Dates

Start date
Nov 15, 2019
Status verified
May 2025
Primary completion
Dec 30, 2022
Completion
Dec 15, 2023

Study Design

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

Arms

  • Experimental: single
    Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. Prescription dose to PTVs as according to the following schema: PTV1: 30 - 50 Gy /10 fx, 5Gy fraction dose, 5 days/week (The prescribed dose to PTV will be decided by physician depending on the dose-volume histogram (DVH) constraints of the normal tissues, such as liver, bowel, etc. The detail of DVH constraints of normal tissues are summarized in the following table) PTV2: 30 Gy /10 fx, 3Gy fraction dose, 5 days/week

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: through study completion, an average of 2.5 year. ]

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