Hepatocellular Carcinoma, Liver Cancer, Adult
Conditions
Keywords
Neoantigen, Vaccine, Dendritic Cell, Personalized, Liver cancer
Brief summary
This is a single-center, open-label, non-randomized, parallel-group phase 1 study evaluating a personalized neoantigen-based dendritic cell vaccine following microwave ablation in patients with hepatocellular carcinoma. After receiving information on both treatment options, eligible participants selected, according to their preference, either microwave ablation followed by Neo-DC vaccination or microwave ablation alone
Interventions
BIOLOGICALNeoantigen Vaccines
HCC (3cm≤D ≤5 cm, fewer than three tumors) patients were treated with Microwave Ablation and 7 courses of neoantigen-based DC vaccines.The first neoantigen-based DC vaccine injection will take place up to 30 days following the completion of Microwave Ablation. The day of the first vaccine injection will be referred to as Day 1.The schedule of vaccination is Day 1, Day 8, Day 15, Day 22, Day 50, Day78, Day106.
PROCEDUREMicrowave Ablation
ALL the HCC patients will be treated by Microwave Ablation.
Sponsors
Chinese PLA General Hospital
Likang Life Sciences Holdings Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed patients with primary hepatocellular carcinoma, HKLC Stage IIa. 2. Age is greater than 18 years old, male or female. 3. The tumor size is 3cm-5cm, and the lesions are \<3. 4. ECOG score \< 2, Child-Pugh classification A or B. 5. The participants freely sign informed consent;
Exclusion criteria
1. Pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent; 2. Portal vein thrombosis or extrahepatic metastases; 3. White blood cell count \<2 x 10e9/L, platelet count \<40 x 10e9/L, serum creatinine \>110 mol/L, aspartate aminotransferase \>3 times upper limit, serum bilirubin \> 2.5 times upper limit, prothrombin time\> 19 seconds. 4. Active uncontrolled infection; 5. Concurrent systemic corticosteroid treatment 6. Primary immunodeficiency or systemic autoimmune disease; being treated with immunosuppressive drugs for other diseases; 7. Clinically significant ischemic heart disease or cardiac failure; 8. The investigator believes that there are other reasons that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of neoantigen-based DC vaccine as measured by the number of subjects experiencing each type of adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. | 1 years |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis. | 2 years |
| Number of participants alive at 2 years | 2 years |
| Progression-free survival at 2 years | 2 years |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORPing Liang, Doctor
Chinese PLA General Hospial
Outcome results
None listed