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Table 1 Eligibility criteria of PRIME-HCC trial

From: PRIME-HCC: phase Ib study of neoadjuvant ipilimumab and nivolumab prior to liver resection for hepatocellular carcinoma

Key inclusion criteria Key exclusion criteria
1. Written informed consent for the trial
2. Aged ≥18 years
3. Confirmed diagnosis of HCC
4. Willing to provide tissue from an excisional biopsy of a tumour lesion
5. Have measurable disease by CT-scan or MRI defined by RECIST 1.1 criteria
6. Ineligible for liver transplantation
7. Medically fit to undergo surgery as determined by the treating medical and surgical oncology team.
8. ECOG-PS 0 or 1
9. Adequate hematologic function, defined as WBC ≥ 2000/μl, ANC ≥ 1500/μl, platelet count ≥50,000/μl and hemoglobin ≥8.5 g/dl without transfusion or Erythropoietin dependency.
10. Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥40 ml/min for those with creatinine levels > 1.5× ULN
11. Adequate hepatic function, defined as total bilirubin ≤1.5× ULN, and ALT/AST levels ≤5× ULN, albumin ≥2.8 g/dL
12. Adequate coagulation function, defined as INR ≤ 1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range
10. Overall Child-Pugh class A
11. Female patient of childbearing potential should have a negative serum pregnancy test within 24 h of her first dose of IMP
12. Women of childbearing potential must be willing to use a highly effective method of contraception
13. Sexually active males must agree to use an adequate method of contraception
1. Extrahepatic metastasis
2. Prior systemic anticancer treatment for HCC, including an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody
3. Prior orthotopic liver transplantation
4. Any major surgery within the 3 weeks prior to enrolment
5. Hepatic encephalopathy
6. Ascites that is refractory to diuretic therapy
7. Is currently receiving anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy or biologic therapy) or has participated or is participating in a study with Nivolumab or Ipilimumab or used an investigational device within 4 weeks of the first dose of IMP
8. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy
9. Known history of active Bacillus Tuberculosis
10. History of known hypersensitivity to any monoclonal antibody or any of their excipients
11. Known additional malignancy that is progressing or requires active treatment a
12. Active autoimmune disease that has required systemic treatment in the past 2 years b
13. Known history of, or any evidence of active, non-infectious pneumonitis
14. Active infection requiring systemic therapy c
15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
16. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
17. Pregnant or breastfeeding
18. Known history of Human Immunodeficiency Virus (HIV; HIV 1/2 antibodies)
19. Received a live vaccine within 30 days of first dose of IMP
  1. CT Computed tomography; MRI Magnetic resonance imaging; ECOG-PS Eastern cooperative oncology group-performance status; WBC White blood cells; ANC Absolute neutrophil count; ULN Upper limit of normal; ALT/AST Alanine/aspartate aminotransferase; IMP Investigational medicinal product; PTT/PT Partial thromboplastin time/prombin time; a Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer; breplacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; c with the exceptions relating to Hepatitis B and C virus