NCT06228963招募中2 期
Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial
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
- 160
- 试验地点
- 1
- 主要终点
- 6-months CR rate
研究概览
简要总结
Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
详细描述
This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Histologically confirmed gastric mucosa-associated lymphoid tissue (MALT) lymphoma;
- •Current infection with Helicobacter pylori (Hp): Diagnosis can be made if any of the following criteria are met: a) Positive result in at least one of the following: RUT (rapid urease test), histological staining, or bacterial culture of gastric mucosal tissue; b) Positive result in 13C or 14C-UBT (urea breath test); c) Positive result in HpSA detection. A positive result in serum Hp antibody test indicates past infection, and patients who have never been treated can be considered as having current infection.
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-
- •Lugano staging I-II
- •Signed informed consent form.
- •Evaluable lesions present.
排除标准
- •Negative for Helicobacter pylori (HP);
- •History of other tumors, except for cured cervical cancer or basal cell carcinoma of the skin;
- •Patients with active HIV and syphilis infections;
- •Pregnant or lactating women;
- •Patients with severe active infections;
- •Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
- •Other comorbidities or conditions that may prevent patients from completing the clinical trial.
研究组 & 干预措施
Experimental group
Experimental
Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib
干预措施: Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib (Drug)
Control group
Active Comparator
Triple therapy for eradication of Helicobacter Pylori
干预措施: Triple therapy for eradication of Helicobacter Pylori (Drug)
结局指标
主要结局
6-months CR rate
时间窗: up to 6 months
the ratio of numbers of patients with complete response to all the participants receiving treatment
次要结局
- 2-year overall survival rate(From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years)
- 3-months CR rate(up to 3 months)
- 2-year progression-free survival (PFS)(From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Throughout the treatment period, up to 6 months)
- 2-year event-free survival (EFS)(From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years)
研究者
Yizhen Liu
Clinical Professor
Fudan University
研究点 (1)
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