Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Официальное название

Orelabrutinib in the First-line Treatment of HP-positive Gastric MALT Lymphoma: a Multicenter, Open-label, Randomized Controlled Trial

Обзор

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

Подробное описание

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

Вмешательства

• Препарат Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib
  Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break) plus Orelabrutinib for 8 weeks (or until progression, intolerable toxicity, death, or withdrawal from the study)
• Препарат Triple therapy for eradication of Helicobacter Pylori
  Triple therapy for H. pylori (oral administration for 2 weeks, followed by a 1-week break)

Первичные конечные точки

• 6-months CR rate [Срок оценки: up to 6 months]

Вторичные конечные точки (5)

• 3-months CR rate [Срок оценки: up to 3 months]
• 2-year progression-free survival (PFS) [Срок оценки: 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]
• 2-year event-free survival (EFS) [Срок оценки: 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]
• 2-year overall survival rate [Срок оценки: 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]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: Throughout the treatment period, up to 6 months]

Критерии участия

Критерии включения

• 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 0-2.
• Lugano staging I-II1.
• Signed informed consent form.
• Evaluable lesions present.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06228963 · iNHL-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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