Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT03067493
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03067493
Study Brief:
Protocol Section:
NCT03067493