Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer

Starting soon · Phase 1/Phase 2

Conditions studied: Gastroesophageal Cancer

In brief

The HER-OIC clinical trial is a Phase 1b/2a study investigating a new combination of treatments for patients with HER2-positive gastroesophageal cancer. Standard treatment for localized gastroesophageal cancer usually involves chemotherapy before and after surgery. This study aims to see if adding targeted therapy (zanidatamab) and immunotherapy (tislelizumab) to standard chemotherapy is safe and effectively eliminates the tumor. The goal is to improve the pathological complete response (pCR) rate, which is the percentage of patients who have no visible cancer cells remaining in the tissue removed during surgery.

Key facts

Study ID

NCT07477444

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

29

Starts

2026-06-01

Expected to finish

2033-06-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary written informed consent from the participant or their legally authorized representative
• At least 18 years of age at the time of signing the consent form
• Agreement to use highly effective birth control methods for both male and female patients
• WHO-ECOG performance status of 0 or 1
• Histologically proven HER2-positive gastroesophageal, esophageal, or gastric adenocarcinoma
• Localized, resectable disease that is fit for perioperative treatment, including surgery
• Adequate hepatic function
• Adequate renal function with an estimated Glomerular Filtration Rate (GFR) > 50 mL/min
• Adequate hematologic function
• Cardiac ejection fraction

You may not qualify if…

• Prior neoadjuvant or definitive chemoradiation
• Squamous cell cancer of the esophagus
• Metastatic or unresectable gastroesophageal cancer
• Active or relapsing autoimmune diseases, with exceptions for controlled Type 1 diabetes, hypothyroidism (hormone replacement only), controlled celiac disease, or certain skin diseases not requiring systemic treatment
• Known hypersensitivity to zanidatamab, tislelizumab, or any of their excipients
• Known Dihydropyrimidine Dehydrogenase (DPD) deficiency
• Active infections requiring systemic treatment
• History of significant cardiac disease
• Previous malignancy within the last 5 years
• Current participation in another interventional Trial involving an investigational medicinal product or device

Full record on ClinicalTrials.gov

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