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

NCT04611165 | Completed Phase 2

• 1 other identifier: NCC2019-0274
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma

Keywords

External Beam Radiation Therapy; Advanced Hepatocellular Carcinoma Who Have Vascular Invasion; Nivolumab

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1) or death from any cause.

  through study completion, an average of 2.5 year.

Study Arms (1)

single

EXPERIMENTAL

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

Drug: Nivolumab

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.

Also known as: EBRT

single

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HCC meeting all of following criteria;
• Signed written informed consent
• Age \>= 20
• Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center17
• Having at least one typical enhanced measurable index lesion (in the liver) by dynamic CT or dynamic contrast-enhanced MRI
• Presence of major vascular invasion on dynamic CT or dynamic MRI
• ① an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava
• ② an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
• Sorafenib naïve or sorafenib experienced
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
• Life expectancy of at least 16 weeks
• Adequate hematologic and hepatic function (should be obtained within 14 days prior to screening:
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1,000/mm3 ③ Platelet count ≥ 50,000/μL

You may not qualify if:

• Patients with HCC meeting all of following criteria;
• Receipt of 2 or more prior systemic therapies for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
• Any type of anticancer agent (including investigational) within 2 weeks before enrollment
• Having active brain metastasis or leptomeningeal metastasis
• Moderate to severe or intractable ascites
• A history or presence of hepatic encephalopathy
• Presence of active bacterial infection
• Untreated active chronic hepatitis B
• History of portal hypertension with bleeding within the past 6 months
• Prior liver transplant
• Uncontrolled severe medical comorbidity
• Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
• Current or past history of hypersensitivity to nivolumab

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Samsung Medical Center: collaborator

Study Sites (1)

National Cancer Center, Korea

Seoul, South Korea

Location

Related Publications (1)

• Kim BH, Park HC, Kim TH, Koh YH, Hong JY, Cho Y, Sinn DH, Park B, Park JW. Concurrent nivolumab and external beam radiation therapy for hepatocellular carcinoma with macrovascular invasion: A phase II study. JHEP Rep. 2023 Dec 21;6(4):100991. doi: 10.1016/j.jhepr.2023.100991. eCollection 2024 Apr.

  PMID: 38463541 DERIVED

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joong Won Park

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 2, 2020
• Study Start: November 15, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 15, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

KR (1)