Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced HCC
Key facts
- Where
- Seoul, Dél-KoreaSee the site
- Phase
- 2. fázis
Where in Dél-Korea
- National Cancer Center, KoreaSeoul, Dél-KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Center, Korea
- Trial code
- NCT04611165
- Record updated
- 2025. május 22.
- Original description
To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRTRead full original descriptionShow less
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
Inclusion: 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; 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.
Exclusion: 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.