CompletedPhase 2

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

South Korea50 participantsStarted 2019-11-15

Plain-language summary

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

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Sorafenib naïve or sorafenib experienced
✓. Child-Pugh class A
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

✕. 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

Progression-free survival (PFS)

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

NCT IDNCT04611165

SponsorNational Cancer Center, Korea

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-12-30