hepatocellular carcinoma
Conditions
Interventions
Case series:neoantigen peptides caccine
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients should volunteer to join the trial and sign the informed consents; 2. Aged 18 to 75 years old male and female; 3. To be diagnosed with resectable hepatocellar carcinoma or intrahepatic cholangiocarcinoma; 4. For participating patients, existence of tumor thrombosis should be visible to the naked eye during the surgery or should be histologically confirmed after surgery; 5. The TNM stage for participating patients should be II-III; 6. The patients should meet/satisfy following Biochemical index: serum bilirubin not greater than 1.5× upper limit of reference range (ULN); ALT or AST not greater than 2.0× ULN; creatinine clearance no less than 60ml/min; 7. The patients should meet/satisfy Hematology Index including: neutrophile granulocyte greater than 1.5×10^9/L; hemoglobin greater than 10g/dL; platelet greater than 100×10^9/L.
Exclusion criteria
Exclusion criteria: 1. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers consider not suitable be included in this study; 2. Patients with history of bone marrow transplantation or organ transplantation; patients with definite hemorrhage of digestive tract or hemorrhagic tendency or with coagulation disorders; 3. Patients with secondary brain metastasis; 4. Patients with any form of immunodeficiency or history of autoimmune disease; 5. Patients received prior treatment with any other immunotherapy within 1 month (such as therapies of immune checkpoint blockers, therapeutic antibodies, immune cell and Immune system modulators); 6. Patients considered that might be allergic to immunotherapy; 7. Patients with drug abuse, clinical or psychological or social factors that might affect the informed consent or the study implementation; 8. Female patients who are pregnant or breast feeding; 9. Patients who are participating in or have participated in other clinical trials within a month; 10. Patients with any other uncertain factors that will affect their safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;immune indexes; | — |
Countries
China
Contacts
Public ContactZeng Yongyi
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed