New hope for eye cancer: targeted drug combo shows promise in early trial
NCT ID NCT07247383
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests a targeted cancer drug called orelabrutinib combined with either low-dose radiation or another drug (rituximab) in 39 people with a rare eye lymphoma (ocular adnexal MALT lymphoma). The goal is to see how well the combination shrinks tumors and how safe it is. Participants have early-stage disease and have not had prior treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Orelabrutinib (a targeted cancer drug) plus either low-dose radiation or rituximab (another cancer drug)
- What this could lead to
- If successful, this could offer a new, less toxic treatment option for a rare eye lymphoma, potentially improving tumor control without harsh side effects.
- What could go wrong
- This is a small, early-phase trial (39 people) with no control group, so results may not apply broadly. The combination may cause side effects or fail to shrink tumors in some patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000, China
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