Dendritic Cell-immunotherapy for Advanced Hepatocellular Carcinoma
A Phase II Trial, Sequential Treatments of Dendritic Cell Vaccination Followed by Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Hepatocellular carcinoma (HCC) is a high malignant tumor with a rapidly progressive clinical course. Surgery is the first choice of the treatment. However, most HCC patients have numerous tumors upon diagnosis, which are not possible to be treated by surgical resection. Currently, several treatment options are applied to treat unresectable HCC, including transcartheter arterial chemoembolization (TACE), percutaneous ethanol injection, radiofrequency ablation, chemotherapy and radiotherapy. Nevertheless, the therapeutic results of these treatment modalities are unsatisfied.
TACE is frequently applied to treat the patients with unresectable HCCs in daily practice. Embolization blocks the arterial blood supply to the tumor and results in tumor necrosis. However, clinical benefits are limited, and the response rate is only 30% Dendritic cells (DC), the most potent antigen-presenting cells, serve as a cancer vaccine to conduct an antigen-specific anti-tumor therapy. Dendritic cell-based immunotherapy has been applied to treat advanced HCC in our previous study. The clinical results of this study verify the feasibility of DC-based immunotherapy for HCC. However, the results are still unsatisfied.
In this proposal, investigators are going to treatment the patients having unresectable HCCs with DC vaccination followed by TACE. DC vaccination can provoke antigen-specific immunity and induce memory T-cells. TACE following DC vaccination may further promote T-cell immunity to treat cancer. Therefore, the specific aims in this study are:
- To determine whether DC vaccination followed by TACE can treat HCC effectively in a clinical trial.
- To determine whether DC vaccination can provoke memory T cells and following TACE can further promote anti-HCC immunity.
The achievement of this clinical trial will help to establish a new strategy for the treatment of unresectable HCC.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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-
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Taoyuan, Taïwan, 33357
- Chang-Gung Memorial Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- advanced HCC patients, no response to standard treatment; WBC : 3000-12000/ul; platelet: >80000/ul; anticipated survival > 3 months, measurable tumors.
Exclusion Criteria:
- HIV; BCLC stage; acute infection; sepsis; other advanced malignancy; acute liver failure;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: dendritic cell treatment
phase 2, one treatment arm
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autologous dendritic cell vaccination
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Treatment-Related Adverse Events
Délai: up to 48 months.
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To evaluate the safety of the treatments by assessing the number of participants with treatment-related adverse events.
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up to 48 months.
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Objective Tumor Response
Délai: From date of first treatment until the date of first documented progression, assessed up to 48 months.
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To evaluate the tumor responses under the treatments as assessed by modified RECIST criteria.
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From date of first treatment until the date of first documented progression, assessed up to 48 months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Survival (OS)
Délai: From date of first treatment to death from any cause, assessed up to 48 months.
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To examine the survival of the patients.
Overall survival is defined as the time from the date of first treatment to death from any cause.
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From date of first treatment to death from any cause, assessed up to 48 months.
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Enhancement of Immunity
Délai: Baseline and at specified intervals up to 48 months.
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evaluate the enhancement of immunity after treatments by measuring quantitative T-cell proliferation via mixed lymphocyte reaction (MLR).
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Baseline and at specified intervals up to 48 months.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wei-Chen Lee, MD, Chang Gung Memorial Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201800519A0
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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