Etude Clinique : IMMUNOGAST

Organe concerné : Estomac

Ligne de traitement : 2ème ligne

Sous-type tumoral :

Schéma de l’essai 

Essai « parapluie » de phase 2 évaluant l’efficacité de combinaisons d’immunothérapies personnalisées chez des patients atteints d’adénocarcinomes de l’estomac métastatiques ou avancés en rechute 

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En L2 ou +.

Main Inclusion Criteria:

  • Histologically and/or cytologically documented recurrent advanced/metastatic gastric or gastroesophageal junction adenocarcinomas* previously treated with a platinum and fluoropyrimidine-based regimen.

    * The gastric or gastroesophageal junction adenocarcinomas that overexpress HER2 should have previously been treated with trastuzumab, except in the case of contraindication.

  • Patients must have documented disease progression
  • Patients who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Accessible tumor lesion (primitive lesion or metastasis) for trial dedicated tumor biopsy.

Main Exclusion Criteria:

  • Residual toxicity from previous treatment grade ≥1, except for alopecia or peripheral neuropathy grade ≤ 2
  • Radiotherapy within 28 days before inclusion, except for palliative radiotherapy if patients recovered from all side effects
  • Congenital risk of bleeding, or acquired coagulopathy, or curative anti-coagulant therapies (except for low molecular weight heparin).
  • Active digestive bleeding within 3 months before inclusion
  • Patients pretreated with one of the experimental drugs, other immune checkpoint inhibitor anti-cancer drugs (anti-PD1, anti-PDL1, anti-CTLA4, …), or with ramucirumab.

Contact

Mme Aminata DAUBA: 0557623450

Mme Camille DUCERF: 0557623447

Centre(s)

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