RFA or Surgical Resection Combined With Neo-MASCT for Primary HCC: a Phase II Trial

Inclusion Criteria before resection/RFA:

1. Aged ≥ 18 years;
2. Primary HCC received RFA/Hepatectomy as the initial treatment; a solitary tumour 2.0-5.0m in diameter; or 2-3 tumours with the largest ≤5.0cm; all without vascular invasion, lymphatic metastasis or distant metastasis (see Appendix 1 for diagnosis criteria).
3. ECOG 0/1 (Appendix 3);
4. Child-Pugh score 5-7 (Appendix 4);
5. A life expectancy of 6 months or more；
6. Adequate haematological, liver and renal function Neutrophil count ≥1.5 x 109/L; platelet count\> 60 x 109/L; Haemoglobin concentration≥9.0 g/dL; Serum albumin≥ 3.0 g/dL; A total bilirubin of less than 1.5 times upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times upper limit of normal; Prothrombin time ≤3s above the control Serum creatinine concentration of 1.5 times the upper limit of the normal range or less; CCR ≥60ml/min
7. Written informed consent

Exclusion Criteria:

1. Pregnant women, lactating women or women planning to be pregnant in 2 years;
2. Intrahepatic metastasis, tumour thrombosis in main trunk or main branches of portal vein, tumour thrombosis in hepatic vein;
3. Systematic use of potent immunosuppressive agents within 6 months or long-term use of them such as corticosteroids, cyclosporine A, et al;
4. Concomitant HIV or HCV infection;
5. Concomitant immunodeficiency diseases or autoimmune diseases (eg. rheumatoid arthritis, Buerger's disease, multiple sclerosis and type I diabetes);
6. Concomitant malignancy or previous malignancy within 5 years before enrolment, excluding skin cancer, local prostate cancer or cervical carcinoma in situ;
7. Organ transplant recipients;
8. Patients with active auto-immune disorder, e.g. autoimmune hepatitis, systemic lupus erythematous etc.;
9. Severe dysfunction of the heart, kidney, or other organs;
10. Severe psychological dysfunction;
11. Sensitive to cytokines, any reagent or associated component in MASCT;
12. Ever participated in any clinical trial of other drugs within 3 months before enrolment;
13. Other patients that investigators think unsuitable to be enrolled.

Inclusion Criteria before immunotherapy:

1. Imaging (enhanced CT or MRI) confirmed completely tumor necrosis or tumor removed 4 weeks after RFA/Hepatectomy；
2. Obtaining adequate samples of the matched tumor and adjacent nontumor normal liver tissues;
3. Sensitive mutations can be detected by gene sequencing in tumour tissue;
4. Prediction of neoantigen peptides ≥10;
5. Synthesized neo antigen peptides ≥5.