NCT05699655招募中2 期
Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer: Randomized Control, Open, Multicenter Trial-2 (TAOS-3B-Trial-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age: 18-70 years of age.
- •Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume >5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version
- •Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.
- •ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
- •No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
- •Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
- •The expected survival time is more than 6 months.
- •For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
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 apatinib and oxaliplatin plus S1
Experimental
干预措施: Tislelizumab (Drug)
Tislelizumab combined with apatinib and oxaliplatin plus S1
Experimental
干预措施: apatinib (Drug)
Tislelizumab combined with apatinib and oxaliplatin plus S1
Experimental
干预措施: oxaliplatin (Drug)
Tislelizumab combined with apatinib and oxaliplatin plus S1
Experimental
干预措施: S-1 (Drug)
oxaliplatin plus S1
Active Comparator
干预措施: oxaliplatin (Drug)
oxaliplatin plus S1
Active Comparator
干预措施: S-1 (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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