Gastro Esophageal Junction Cancer, Stomach Cancer
Conditions
Keywords
short term immunotherapy, surgical resection, atezolizumab, capecitabine, oxaliplatin, docetaxel
Brief summary
In this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment. The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.
Detailed description
In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction. All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.
Interventions
DRUGAtezolizumab
atezolizumab 1200 mg 5 cycles
DRUGCapecitabine
capecitabine 850 mg /m2 4 cycles
DRUGOxaliplatin
oxaliplatin 100 mg/m2 4 cycles
DRUGDocetaxel
docetaxel 50 mg/m2 4 cycles
Sponsors
Hoffmann-La Roche
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed informed consent * patients age 18 and older * primary resectable, histologically confirmed gastric or GEJ adenocarcinoma
Exclusion criteria
* no signs of distant metastases * no active or history of autoimmune disease or immune deficiency * no significant cardiovascular disease * no major surgical procedure within 4 weeks prior to initiation of study treatment * no current treatment with anti-viral therapy or HBV * no pregnancy or breastfeeding * no history of malignancy within 3 years prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events following treatment (safety) | until 100 days after last patient last study drug treatment | Adverse events will be assessed (according to CTC-AE v4.0) during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pathological tumor regression grade | Within 6 months after last patient inclusion | determined using the Mandard tumor regression grading system |
Countries
Netherlands
Outcome results
None listed