NCT06396585尚未招募2 期
The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction : a Prospective，Single-arm, Phase II Trial (TASTE Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patient ≥ 18 and ≤ 75 years.
- •Histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (AEG, Siewert II-III)，uT3, uT4a, uT4b any N category, M0, or any T N+ M0 patient
- •No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
- •Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs).
- •Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
- •The expected survival time is more than 6 months.
- •Women of childbearing age shall be those who agree to use contraception (such as intrauterine devices, contraceptives or condoms) during the study and for 6 months after the end of the study; those who have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating; and men who agree to use contraception during the study and for 6 months after the end of the study.
- •Hematological, hepatic and renal function parameters adequate to allow surgical procedure and chemotherapy
- •Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
排除标准
- •Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
- •Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed, if it was still positive after reexamination, gastroscopy was required.
- •Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- •A history of immunodeficiency, including HIV testing positive.
- •Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
- •Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
- •HER2 positive is known.
- •Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
研究组 & 干预措施
Tislelizumab combined with anlotinib chemotherapy
Experimental
干预措施: Tislelizumab (Drug)
Tislelizumab combined with anlotinib chemotherapy
Experimental
干预措施: Anlotinib (Drug)
Tislelizumab combined with anlotinib chemotherapy
Experimental
干预措施: Oxaliplatin (Drug)
Tislelizumab combined with anlotinib chemotherapy
Experimental
干预措施: Tegafur (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
次要结局
- Major pathological response(4 weeks after surgery)
- Objective Response Rate (ORR)(At the end of Cycle 3 (each cycle is 21 days))
研究者
研究点 (1)
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