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New treatment option for MALT Lymphoma of Stomach
Official title Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma
ClinicalTrials.gov ID: NCT06228963
What this study is testing
What is Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib?
Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malt lymphoma of stomach.
Also referred to as anti-HP and Orelabrutinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
- Lugano staging I-II1.
You likely can't join if
- 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);
See the full eligibility criteria
- 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...
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
- Lugano staging I-II1.
- Signed informed consent form.
- Evaluable lesions present.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.