Clinical trial · Interventional
A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation | Procedure | — | UNRESOLVED |
| Neoantigen Vaccines | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Microwave Ablation + Neoantigen Vaccines
- description
- The HCC patients will be treated firstly by Microwave Ablation, and then treated by courses of Neoantigen Vaccines.
- interventionNames
- Biological: Neoantigen Vaccines
- Procedure: Microwave Ablation
- type
- ACTIVE_COMPARATOR
- label
- Microwave Ablation
- description
- The HCC patients will be treated only by Microwave Ablation.No vaccine will be used.
- interventionNames
- Procedure: Microwave Ablation
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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