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Advanced Hepatocellular CarcinomaPhase 2NextrahNCT04611165

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

A Phase 2 study testing Nivolumab in people with Advanced Hepatocellular Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRT Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
15 Nov 2019to 15 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Total bilirubin < 2.5 mg/dL
  • Serum albumin >2.8 g/dL ⑥ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN) ⑦ Prothrombin time in INR ≤ 1.8 × ULN ⑧ Serum creatinine ≤ 1.5 mg/dL
  • Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center, Korea

    Seoul

Other trials in South Korea

About this study

Official title: 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

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

Read the 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))

Being tested
Nivolumab
Keywords
External Beam Radiation Therapy, Advanced Hepatocellular Carcinoma Who Have Vascular Invasion, Nivolumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called EBRT

    • 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 groups in NCT04611165
Study groupRoleWhat they receive
singleExperimentalNivolumab 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
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 2.5 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2020
  2. Study start15 Nov 2019
  3. Primary completion30 Dec 2022
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611165
Sponsor's protocol ID
NCC2019-0274
Acronym
Nextrah
Status last verified
May 2025
First submitted
28 Sep 2020
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38463541

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Advanced Hepatocellular Carcinoma, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: through study completion, an average of 2.5 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04611165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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