Clinical trial NCT03674073: A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
Official title: A Study to Assess the Safety, Feasibility, and Immunogenicity of Personalized Neoantigen-based Dendritic Cell Vaccine in Combination With Microwave Ablation to Treat Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Liver Cancer, Adult
Keywords: Neoantigen
Vaccine
Dendritic Cell
Personalized
Liver cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Likang Life Sciences Holdings Limited
First posted: 2018-09-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single institution, open-label, multi-arm, pilot study of a personalized neoantigen-based dendritic cell (DC) vaccine combined with microwave ablation in subjects with Hepatocellular Carcinoma (HCC). Patients with HKLC stage IIa HCC are eligible for enrollment. In this study, the investigators are looking at the safety, feasibility of the personalized neoantigen-based DC vaccine combined with microwave ablation as well as the T cell immune response to the vaccine.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 years
Secondary outcomes:
measure: Immunogenicity of the neoantigen-based DC vaccine as measured by the frequency of antigen -specific T cells using ELISPOT analysis and ICS analysis.
timeFrame: 2 years
measure: Number of participants alive at 2 years
timeFrame: 2 years
measure: Progression-free survival at 2 years
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospial
name: Ping Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: