Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma

Inclusion Criteria:

* 1\. Aged ≥18 years, with no gender restriction;
* 2\. Patients with OAML confirmed by histopathology;
* 3\. Ann Arbor stage (I\~II);
* 4\. ECOG performance status score of 0-2;
* 5\. No previous systemic treatment;
* 6\. Major organ functions meet the following criteria:
* (1). Blood routine: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥75g/L; In case of bone marrow involvement, absolute neutrophil count ≥1.0×10⁹/L, platelet count ≥50×10⁹/L, hemoglobin ≥50g/L;
* (2). Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; Serum creatinine ≤1.5×ULN; Serum amylase ≤ULN;
* (3). Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN.
* 7\. Expected survival time ≥3 months
* 8\. Voluntarily sign a written informed consent form before trial screening.

Exclusion Criteria:

* 1\. Current or previous history of other malignant tumors, except those with evidence of no recurrence or metastasis for at least 5 years after radical treatment;
* 2\. Lymphoma involving the central nervous system or transformed to high-grade lymphoma;
* 3\. Non-hematological toxicities from previous anti-tumor treatment have not recovered to ≤ Grade 1 (except alopecia);
* 4\. Uncontrolled or significant cardiovascular diseases, including:
* (1). Congestive heart failure of New York Heart Association (NYHA) Class II or higher, unstable angina pectoris, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmia requiring treatment at screening, or left ventricular ejection fraction (LVEF) \< 50%;
* (2). Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
* (3). History of clinically significant QTc interval prolongation, or QTc interval at screening (female \> 470ms, male \> 450ms);
* (4). Subjects with symptomatic coronary heart disease requiring medication;
* (5). Subjects with poorly controlled hypertension (blood pressure not reaching the target after more than 1 month of using 3 or more reasonable and tolerable maximum-dose antihypertensive drugs (including diuretics) on the basis of lifestyle modification, or blood pressure can only be effectively controlled by taking 4 or more antihypertensive drugs);
* 5\. Active bleeding within 2 months before screening, or current use of anticoagulant drugs, or clear bleeding tendency as judged by the investigator;
* 6\. Urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2g/24h;
* 7\. History of deep vein thrombosis or pulmonary embolism within 6 months before screening;
* 8\. History of organ transplantation or allogeneic bone marrow transplantation;
* 9\. Major surgery performed within 6 weeks before screening or minor surgery performed within 2 weeks before screening. Major surgery refers to surgery requiring general anesthesia, while endoscopic examination for diagnostic purposes is not considered major surgery. Insertion of vascular access devices is exempted from this exclusion criterion;
* 10\. Active infection, or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS, or other severe infectious diseases;
* 11\. Subjects with severe pulmonary function impairment such as current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc.;
* 12\. Previous treatment with BTK inhibitors, BCR pathway inhibitors (e.g., PI3K, Syk) and BCL-2 inhibitors;
* 13\. Eligible for and planning to undergo stem cell transplantation;
* 14\. Any mental or cognitive impairment that may limit the understanding and execution of the informed consent form and compliance with the study;
* 15\. Subjects with drug addiction or alcoholism;
* 16\. Pregnant or lactating women, and fertile subjects who are unwilling to take contraceptive measures;
* 17\. Continuous use of drugs with moderate-to-severe inhibitory or strong inductive effects on cytochrome P450 CYP3A;
* 18\. Other conditions deemed unsuitable for participating in this trial by the investigator.