This is a multicenter, randomized, controlled, open-label study comparing perioperative atezolizumab with FLOT chemotherapy versus FLOT alone in patients with locally advanced, operable adenocarcinoma of the stomach or GEJ with high immune responsiveness.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have provided written informed consent
✓. In the investigator's judgement, is willing and able to comply with the study protocol including the planned surgical treatment
✓. Female and male patients\* ≥ 18 years of age
✓. Diagnosed with histologically confirmed adenocarcinoma of the GEJ (Type I-III) or the stomach (cT2, cT3, cT4, any N category, M0), or (any T, N+, M0) that:
✓. is not infiltrating any adjacent organs or structures by CT or MRI evaluation
✓. does not involve peritoneal carcinomatosis
✓. is considered medically and technically resectable Note: the absence of distant metastases must be confirmed by CT or MRI of the thorax and abdomen, and, if there is clinical suspicion of osseous lesions, a bone scan. If peritoneal carcinomatosis is suspected clinically, its absence must be confirmed by laparoscopy. Diagnostic laparoscopy is mandatory in patients with T3 or T4 tumors of the diffuse type histology in the stomach.
✓. No prior cytotoxic or targeted therapy
Exclusion criteria
✕. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein; Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
✕. Any known contraindication (including hypersensitivity) to docetaxel, 5-FU, leucovorin, or oxaliplatin.
What they're measuring
1
Comparison of Event free survival (EFS) between arms
Timeframe: 10 years
Trial details
NCT IDNCT03421288
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Prior allogeneic bone marrow transplantation or prior solid organ transplantation
✕. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
✕. Positive test for human immunodeficiency virus (HIV)
✕. Active hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test prior to randomization) or hepatitis C Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction testing is negative for HCV ribonucleic acid (RNA).