NCT06730373招募中2 期
A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)
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
- 110
- 试验地点
- 26
- 主要终点
- Objective remission rate (ORR)
研究概览
简要总结
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
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
- •Aged18-80 years, gender is not limited;
- •Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
- •HER2-Positive (IHC3+or IHC2+/FISH+) ;
- •Has at least 1 measurable lesion as determined by RECIST 1.1;
- •There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Adequate organ function;
- •The life expectancy is at least 3 months;
排除标准
- •Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
- •Cardiovascular and cerebrovascular events that are not well controlled;
- •Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.
- •Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
- •Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
- •Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
- •Brain metastasis or leptomeningeal metastasis;
- •Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
- •Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
- •Any major surgery was performed ≤ 28 days before the first trial drug administration;
- •History of allogeneic stem cell transplantation or organ transplantation;
研究组 & 干预措施
Disitamab Vedotin+Sintilimab+S-1
Experimental
干预措施: S-1 (Drug)
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Active Comparator
干预措施: Sintilimab (Drug)
Disitamab Vedotin+Sintilimab+S-1
Experimental
干预措施: Disitamab Vedotin (Drug)
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Active Comparator
干预措施: Trastuzumab (Drug)
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Active Comparator
干预措施: Oxaliplatin (Drug)
Disitamab Vedotin+Sintilimab+S-1
Experimental
干预措施: Sintilimab (Drug)
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Active Comparator
干预措施: Capecitabine (Drug)
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Active Comparator
干预措施: 5-FU (Drug)
Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
Objective remission rate (ORR)
时间窗: 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
次要结局
- Progression-free survival (PFS)(12 months after the last subject participating in)
- Overall survival (OS)(12 months after the last subject participating in)
- Duration of relief (DOR)(12 months after the last subject participating in)
- Disease control rate (DCR)(6 months after the last subject participating in)
- Safety(adverse event)(Up to approximately 2 years)
研究者
Lian Liu, MD, PHD
Director
Qilu Hospital of Shandong University
研究点 (26)
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