eoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in non-metastatic, resectable gastric and GE-junction cancer. ;The PANDA trial - The PANDA trial

ederlands Kanker Instituut0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Primary resectable, gastro-oesophageal junction adenocarcinoma or gastric
•adenocarcinoma
•- WHO performance status of 0 or 1
•- No distant metastases
•- CT-scan < 4 weeks to registration
•- Patients must be willing to undergo esophagogastroscopy and biopsies prior to
•start of treatment and during treatment at set timepoints

•- Clinical symptoms or radiological suspicion of perforation
•- Active auto-immune disease or documented history of autoimmune disease, or
•other medical conditions requiring systemic steroid or immunosuppressive
•medications, except for subjects with vitiligo, diabetes mellitus type 1,
•residual hypothyroidism due to autommune condition only requiring hormone
•replacement, psoriasis or resolved childhood asthma/atopy not requiring
•systemic treatment
•- Conditions requiring systemic treatment with either corticosteroids (>10mg
•daily prednisone equivalents or other immunosuppressive medications within 14
•days of study drug administration. Inhaled or topical steroids and adrenal
•replacement doses > 10 mg daily prednisone equivalents are permitted in the
•absence of active autoimmune disease;
•- Previous treatment with immune checkpoint inhibitors
•- History of allergy to study drug components, hypersensitivity reaction to any
•monoclonal antibody
•- Positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus
•ribonucleic acid (HCV antibody) indicating acute or chronic infection;
•- History of testing positive human immunodeficiency virus or known acquired
•immunodeficiency syndrome (AIDS)
•- Malignancies other than disease under study within 3 years prior to
•inclusion, requiring systemic treatment or judged by the investigators to be
•incompatible with the study, except for non-melanoma skin cancer.

发起方

ederlands Kanker Instituut