Perioperative Zanidatamab Combined With Chemotherapy in Operable HER2 Positive Locally Advanced Operable Gastroesophageal Adenocarcinoma (GEA): A Phase 1b/2a Single-Arm Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 29
- 主要终点
- Pathological Complete Response (pCR) Rate (Total Population)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Perioperative Zanidatamab and Chemotherapy
This is a single-arm, open-label trial where participants are assigned to receive specific interventions (zanidatamab, chemotherapy, tislelizumab) based on the study protocol.
干预措施: Zanidatamab Combined with Chemotherapy (Drug)
结局指标
主要结局
Pathological Complete Response (pCR) Rate (Total Population)
时间窗: 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)
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.
Incidence of Qualifying Safety Events (Phase 1b Safety Run-in)
时间窗: 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)
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.
次要结局
未报告次要终点