Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 22, 2019

Primary Completion Date

March 15, 2023

Study Completion Date

June 15, 2026

Conditions
Gastroesophageal Junction AdenocarcinomaStomach Neoplasms
Interventions
COMBINATION_PRODUCT

Avelumab addition to perioperative chemotherapy in GC and GEJC

Avelumab addition to perioperative chemotherapy in GC and GEJC. Peri-operatory treatment consisting of four cycles (each cycle is 14 days) of neoadjuvant chemotherapy (docetaxel, oxaliplatin and fluorouracil/leucovorin) plus avelumab previous to surgery. Surgery is recommended to be scheduled 4 to 6 weeks after the last dose. Afterwards (4 to 10 weeks after surgery), four cycles of adjuvant therapy with the same schema, followed by avelumab up to one year. There will be be a follow-up of 5 years.

Trial Locations (1)

Unknown

Vall d'Hebron Institute of Oncology, Barcelona

All Listed Sponsors
lead

Vall d'Hebron Institute of Oncology

OTHER

NCT03979131 - Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) | Biotech Hunter | Biotech Hunter