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

Phase 2

Recruiting

• Conditions: stomach cancer; gastric cancer; 10017990

• Registration Number: NL-OMON50269
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified