Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT07165769
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 80 years, male or female
* Histologically or cytologically confirmed SBLPN requiring active treatment;
* No prior systemic therapy for SBLPN received;
* ECOG performance status of 0-2;
* Anticipated life expectancy ≥6 months;
* Laboratory parameters (hematologic and biochemical) meeting the following criteria:
* a. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L;
* b. Total bilirubin (TBIL) ≤2.0 × upper limit of normal (ULN);
* c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
* d. Creatinine clearance ≥50 mL/min (calculated via Cockcroft-Gault formula or direct measurement).
* Men and women of childbearing potential must agree to use medically approved contraception throughout the study and for 4 weeks after treatment discontinuation;
* Participants must voluntarily enroll in the study and provide written informed consent.
Exclusion Criteria:
* History of central nervous system (CNS) disorders (including CNS lymphoma) diagnosed within 1 year prior to enrollment.
* Other primary malignancies within the past 3 years (excluding non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ, or squamous intraepithelial lesions on PAP smear).
* Exposure to any investigational drugs, antimicrobial agents, or participation in other interventional clinical trials within 4 weeks prior to enrollment.
* Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated requirement for major surgery during the study.
* Prior use of investigational agents targeting SBLPN.
* Active immunodeficiency, autoimmune diseases, prolonged systemic corticosteroid therapy (\>10 mg/day prednisone equivalent) within 7 days prior to enrollment, or any immunosuppressive therapy.
* Severe hepatic dysfunction (e.g., severe jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome), cachexia, multiorgan failure, or severe renal impairment.
* Clinically significant cardiovascular comorbidities:
New York Heart Association (NYHA) class III/IV heart failure; Myocardial infarction within 6 months prior to enrollment; Uncontrolled arrhythmias (including QTc interval ≥480 ms); Poorly controlled hypertension (systolic ≥150 mmHg/diastolic ≥100 mmHg despite antihypertensives); Unstable angina.
* Bleeding diathesis or coagulation disorders; thrombotic events within 3 months prior to enrollment.
* Hypersensitivity to active ingredients or excipients of the investigational drugs.
* Pregnancy, lactation, or women of childbearing potential unwilling/unable to use contraception.
* Other conditions deemed unsuitable for participation by the investigator (e.g., compromised protocol compliance or safety risks).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07165769
Study Brief:
Protocol Section:
NCT07165769