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NCT03674073
A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma, Liver Cancer, Adult
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Chinese PLA General Hospital
Location: Chinese PLA General Hospital Beijing Beijing Municipality
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
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 \ 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.
Source: ClinicalTrials.gov (NCT03674073). StuddyBuddy aggregates publicly available trial information.