Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanidatamab Combined with Chemotherapy.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Zanidatamab Combined With Chemotherapy in Operable HER2 Positive Locally Advanced Operable Gastroesophageal Adenocarcinoma (GEA): A Phase 1b/2a Single-Arm Trial
Overview
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.
Interventions
- Drug Zanidatamab Combined with Chemotherapy
This intervention combines perioperative zanidatamab with chemotherapy and the PD-1 inhibitor tislelizumab for HER2-positive gastroesophageal adenocarcinoma
Primary outcome measures
- Incidence of Qualifying Safety Events (Phase 1b Safety Run-in) [Time frame: During the neoadjuvant period, which start from the first treatment administration and continues until the end of the fourth preoperative 14-day cycle (8 weeks)]
- Pathological Complete Response (pCR) Rate (Total Population) [Time frame: At the time of surgery, which occurs 4 to 12 weeks after the last dose of pre-operative treatment (approximately 12 to 20 weeks after the first dose)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07477444 · S71017