Évaluation de l'intérêt d'associer un vaccin anticancéreux inducteur CD4 Th1 dérivé de la télomérase et de l'atezolizumab plus bevacizumab dans le carcinome hépatocellulaire non résécable

Essai clinique

Type : Académique
Statut : Ouvert
Phase : II
Étape du traitement : Traitements combinés
Date d'ouverture : 27/02/2022
Date clôture : 30/09/2027
Promoteur : Centre Hospitalier Universitaire de Besancon
Progression du cancer: Loco-régional et à distance
Résumé :

The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)

Domaines/spécialités :
  • Cancers digestifs
    • Foie –Voie biliaire
Pathologies :
  • Carcinome in situ du foie, de la vésicule et des voies biliaires - Cim10 : D015
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  1. Signed informed consent
  2. Histologically confirmed hepatocellular carcinoma
  3. Locally advanced, metastatic, or unresectable disease
  4. Patient who had not previously received systemic anti-cancer treatment
  5. Age ≥ 18 years
  6. Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
  7. Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to National Cancer Institute [NCI] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia
  8. Performance status < 2
  9. Child-Pugh Class A status
  10. BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system
Critères d’exclusion :
  1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
  2. Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
  3. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
  4. Current participation in a study of an investigational agent or in the period of exclusion

  5. Patient under guardianship, curatorship or under the protection of justice

    Cancer-specific exclusion criteria:

  6. Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  7. Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
  8. Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period

  9. Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed

    Non-eligible to treatment:

  10. History of encephalopathy
  11. Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
  12. Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition

Centres d'investigation

En cours
Nom : CHU de Besançon
Ville : BESANÇON (25)
RESPONSABLE MÉDICAL
Aucun responsable médical renseigné
CONTACT TECHNIQUE
Nom : BERTHOD
Prénom : Diane
Téléphone : 03 70 63 24 03
Email : dberthod@chu-besancon.fr
En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Pr GHIRINGHELLI
Prénom : François
Téléphone : Non disponible
Email : fghiringhelli@cgfl.fr
CONTACT TECHNIQUE
Nom : PASQUIER
Prénom : Marie-Lou
Téléphone : 03 80 73 75 00
Email : mlpasquier@cgfl.fr

Référentiels Oncologik

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