Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Re… (NCT03979131) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC)
Spain40 participantsStarted 2019-08-22
Plain-language summary
Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric cancer (GC) or Gastroesphageal Junction cancer (GEJC)
The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response. Conclusively, the survival of these patients would improve.
The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy (docetaxel, oxaliplatin and fluorouracil/leucovorin) improves efficacy in terms of pathological complete response (pCR) rate, in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically proven, gastric or GEJ adenocarcinoma (Siewert I-III).
✓. Availability of a paraffin block from the diagnostic endoscopic biopsy (and a fresh biopsy if possible), and a second tumor block (fresh + paraffin) from the surgical specimen.
✓. Have evaluable disease as defined by RECIST 1.1 and determined by investigator assessment, with the absence of distant metastases on CT scan of thorax, abdomen and pelvis.
✓. Patient medically fit and amenable to gastrectomy/esophagectomy with curative intent as confirmed by a multidisciplinary team discussion.
✓. UICC tumor stage Ib (T1N1 only, T2N0 not eligible) to IIIC, as defined by CT, according to the 7th AJCC Edition.
✓. Age ≥ 18 years.
✓. WHO performance status 0-1.
✓. Adequate organ function (assessed within 7 days prior treatment initiation):
✕. Has had previous therapy for gastric or GEJ cancer.
✕. Known hypersensitivity to the components of anti-PD-L1, docetaxel, oxaliplatin, fluorouracil/leucovorin.
✕. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
✕. Previous malignancy within the last 5 years, except for adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer, or other curatively treated cancer without impact on the patient's overall prognosis according to the judgment of the investigator.
✕. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those condition should be discussed with the patient before registration in the trial.
✕. History of clinically significant comorbidities.
✕. Patients medically unfit for FLOT chemotherapy, according to the local guidance.