Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA) (PANDA)
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|ClinicalTrials.gov Identifier: NCT03448835|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 20, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Cancer Gastro Esophageal Junction Cancer||Drug: Atezolizumab Drug: Capecitabine Drug: Oxaliplatin Drug: Docetaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single group, open label|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial|
|Actual Study Start Date :||March 7, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: atezolizumab and chemotherapy
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
atezolizumab 1200 mg 5 cycles
Other Name: MPDL3280A
capecitabine 850 mg /m2 4 cycles
Other Name: L01BC06
oxaliplatin 100 mg/m2 4 cycles
Other Name: L01XA03
docetaxel 50 mg/m2 4 cycles
Other Name: L01CD02
- Incidence of adverse events following treatment (safety) [ Time Frame: until 100 days after last patient last study drug treatment ]Adverse events will be assessed (according to CTC-AE v4.0) during treatment
- pathological tumor regression grade [ Time Frame: Within 6 months after last patient inclusion ]determined using the Mandard tumor regression grading system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448835
|Contact: Marieke van de Belt||+3120512 ext email@example.com|
|Marieke van de Belt||Recruiting|
|Amsterdam, Netherlands, 1066CX|
|Contact: Marieke van de Belt +3120512 ext 1926 firstname.lastname@example.org|
|Contact: G. Nieuwenhuijzen|
|Principal Investigator:||Myriam Chalabi, MD||Antoni van Leeuwenhoek|