NCT07477444

Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer

Perioperative Zanidatamab Combined With Chemotherapy in Operable HER2 Positive Locally Advanced Operable Gastroesophageal Adenocarcinoma (GEA): A Phase 1b/2a Single-Arm Trial

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastroesophageal Cancer

Interventions

Type	Name	Description
DRUG	Zanidatamab Combined with Chemotherapy	This intervention combines perioperative zanidatamab with chemotherapy and the PD-1 inhibitor tislelizumab for HER2-positive gastroesophageal adenocarcinoma

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2033-06-01
• First posted: 2026-03-17
• Last updated: 2026-03-20