Clinical trial · Interventional
Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
- 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)
The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| injection of the cell therapy product | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 3 days after each injection
- description
- The main aim of this study is to test the absence of toxicity of the injection of autologist dendritic cells loaded with specific peptides of the AFP, for patients with hepatocellular carcinoma and already treated.
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 3 weeks after the last injection
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 3 months after the last injection
Secondary outcomes (3)
- measure
- Analysis of T lymphocytes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Pre-inclusion Criteria : * Adults (men or women) aged between 18 and 80 years * Patients affiliated to a social security reimbursement system * Signed informed consent * Hepatocellular carcinoma * At least one dosage with Alpha-foeto-protein ≥ 40 ng/ml * Patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or Sorafenib. Inclusion Criteria: * Negative test for pregnancy or effective contraception * Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis- * HLA A 0201 group Exclusion Criteria: * Life expectancy \< 3 months * Pregnancy or breast-feeding * Severe auto-immune disease * Another malignant tumor except if considered as cured since more than 5 years * History of uncontrolled psychiatric condition * Risk factors of Creutzfeldt Jacobs disease * Decompensated cirrhosis(ascites or Child-Pugh score greater than 8) * Hepatic transplantation
References
Publications (0)
Data not yet available