Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial

Conditions
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Stomach Cancer, Gastro Esophageal Junction Cancer

Intervention / Treatment
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* Drug: Atezolizumab
* Drug: Capecitabine
* Drug: Oxaliplatin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atezolizumab and chemotherapy<br>1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel | Drug: Atezolizumab<br>* atezolizumab 1200 mg 5 cycles<br>* Other names: MPDL3280A;Drug: Capecitabine<br>* capecitabine 850 mg /m2 4 cycles<br>* Other names: L01BC06;Drug: Oxaliplatin<br>* oxaliplatin 100 mg/m2 4 cycles<br>* Other names: L01XA03;Drug: Docetaxel<br>* docetaxel 50 mg/m2 4 cycles<br>* Other names: L01CD02;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events following treatment (safety) | Adverse events will be assessed (according to CTC-AE v4.0) during treatment | until 100 days after last patient last study drug treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological tumor regression grade | determined using the Mandard tumor regression grading system | Within 6 months after last patient inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short term immunotherapy, surgical resection, atezolizumab, capecitabine, oxaliplatin, docetaxel