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.
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
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
Single group
Zanidatamab Combined with Chemotherapy
DrugThis intervention combines perioperative zanidatamab with chemotherapy and the PD-1 inhibitor tislelizumab for HER2-positive gastroesophageal adenocarcinoma
Incidence of Qualifying Safety Events (Phase 1b Safety Run-in)
The primary safety endpoint is the incidence of "qualifying safety events," defined as Grade ≥3 diarrhea or any Grade ≥3 treatment-emergent toxicity that results in the inability to administer the planned neoadjuvant chemotherapy or zanidatamab.
Pathological Complete Response (pCR) Rate (Total Population)
The primary efficacy endpoint is the improvement of the pCR rate, defined as the percentage of patients with no residual invasive cancer in the completely resected tumor specimen and sampled regional lymph nodes. The study aims to detect an improvement from a historical 8% to a 30% pCR rate across the total 29-patient cohort.
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This trial is not recruiting at the moment. You can still explore other options:
