A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion

NCT06828380 | Recruiting Phase 2

• 1 other identifier: NCC2024-0308
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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 the investigator according to RECIST v1.1 criteria or death from any cause.

  up to approximately 3 years

Secondary Outcomes (6)

• OS(overall survival)

  up to approximately 3 years

• TTP(Time to progression)

  up to approximately 3 years

• ORR(Objective response rate)

  up to approximately 3 years

• DCR(Disease control rate)

  up to approximately 3 years

• DoR(Duration of response)

  up to approximately 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

concurrent therapy of Immunotherapy based combination therapy and Proton beam radiation therapy

Radiation: Particle beam radiation therapy

Arm B

NO INTERVENTION

concurrent therapy of Immunotherapy based combination therapy

Interventions

Particle beam radiation therapy RADIATION

The prescribed dose and fractionation for proton therapy to the PTV will be determined by the physician, taking into account the dose-volume constraints of normal tissues such as the liver and bowel.

Arm A

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form
• Age \>= 19 at the time of signing Informed consent form
• Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association -National Cancer Center
• Unresectable and/or locally advanced or metastatic disease showing major vascular invasion
• a. Presence of major vascular invasion on dynamic CT or dynamic MRI (1+2)
• an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava
• an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases
• Having at least one measurable target lesion (per RECIST v1.1)
• a. Participants who received prior locoregional therapy (e.g., radiofrequency ablation, microwave ablation, transarterial chemoembolization, transarterial radioembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with locoregional therapy or the target lesion(s) within the field of locoregional therapy have subsequently progressed in accordance with RECIST v1.1.
• Child-Pugh class A
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to screening:
• Hemoglobin ≥ 8.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1,000/mm3
• Platelet count ≥ 50,000/μL

You may not qualify if:

• Fibrolamellar carcinoma or sarcomatoid carcinoma
• Receipt of 2 or more prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
• Receipt of other first-line systemic therapy than immune checkpoint inhibitor-based regimen
• Receipt of prior radiation therapy to liver
• a. Participants are excluded if the potential radiation field overlaps with a previously irradiated area.
• Receipt of locoregional therapy for HCC within 28 days prior to initiation of study treatment or non-recovery from complications due to the procedure (radiofrequency ablation, microwave ablation, cryoablation, trans-arterial embolization including chemo- and radio-embolization, or radiation therapy).
• a. A 7-day washout is permitted for palliative radiation to bone lesions
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, or multiple sclerosis with following exceptions:
• Patients with hypothyroidism stable on hormone replacement
• Controlled type 1 diabetes mellitus and on an insulin regimen
• Any chronic skin condition that does not require systemic therapy
• Prior allogeneic stem cell or solid organ transplantation
• Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to initiation of study treatment
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• Having active brain metastasis or leptomeningeal metastasis

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (2)

National Cancer Center

Goyang, South Korea

RECRUITING

Samsung Medical Center, Seoul

Seoul, South Korea

RECRUITING

Central Study Contacts

Yumi Yang

CONTACT

+82-10-3134-9044; 75427@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 14, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): August 6, 2028
• Study Completion (Estimated): August 6, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

KR (2)