A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV

Inclusion Criteria: * Aged ≥18 years * Diagnosis of polycythemia vera (PV) according to the 2022 International Consensus Classification (ICC) criteria; * Presence of at least one of the following disease manifestations, defined as: a. Peripheral hematological abnormality: HCT ≥45% and/or PLT \>400×10⁹/L and/or WBC ≥10×10⁹/L in the absence of phlebotomy; b. Presence of weight loss \>10% over the past 6 months, night sweats, pruritus, or unexplained fever (\>37.5°C); c. Progressive splenomegaly (previous splenomegaly with an increase \>5 cm from baseline or newly developed splenomegaly); d. History of prior thrombotic or hemorrhagic events; * No current plan for stem cell transplantation; * Life expectancy \>24 weeks; * ECOG performance status 0-2; * Able to swallow tablets; * No prior treatment with interferon or JAK inhibitors (patients who have received hydroxyurea or phlebotomy are eligible); * No receipt of growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks prior to screening, with platelet count ≥100×10⁹/L and ANC ≥1.5×10⁹/L; * Adequate major organ function, defined asALT and AST ≤2.5 × ULN;DBIL and TBIL ≤2.0 × ULN;Serum creatinine ≤1.5 × ULN; * Peripheral blood blasts 0%; * Voluntary signed informed consent in accordance with ethics committee requirements; * Able to comply with study and follow-up procedures. Exclusion Criteria: * Any significant clinical or laboratory abnormality considered by the investigator to affect safety assessment, such as:a. Uncontrolled diabetes (\>250 mg/dL or \>13.9 mmol/L);b. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg);c. Peripheral neuropathy (Grade ≥2 according to NCI-CTCAE V5.0). * History of congestive heart failure (Grade ≥3 according to NCI-CTCAE V5.0), uncontrolled or unstable angina pectoris or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening. * Patients who have undergone major surgery within 4 weeks prior to screening and have not fully recovered. * Patients who have received PEG-IFN-α-2a or have a history of ³²P therapy within 5 weeks prior to screening. * Patients diagnosed with primary immunodeficiency syndrome (e.g., X-linked agammaglobulinemia and common variable immunodeficiency). * Patients with arrhythmic disorders requiring treatment at screening (except digoxin). * Patients with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening. * Patients with active pulmonary infection indicated by chest CT examination at screening. * Patients with a prior confirmed diagnosis of active tuberculosis infection or those with a positive interferon-gamma release assay at screening confirmed as active tuberculosis infection by the investigator. * Patients who have undergone splenectomy or have received splenic radiation therapy within 48 weeks prior to screening. * Patients who are HIV positive, have active hepatitis B virus infection (HBsAg positive and HBV-DNA positive or above the normal reference range), or are anti-HCV antibody positive with HCV-RNA positive at screening. * Patients with epilepsy or those using psychiatric or sedative medications at screening (except for Estazolam tablets). * Female patients who are planning to become pregnant, are pregnant, or are breastfeeding, and patients who are unable to use effective contraception throughout the study period; male patients who do not use condoms during the administration period and for 2 days (approximately 5 half-lives) after the last dose. * Patients with a history of malignancy within the past 5 years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). * Presence of other severe diseases that, in the investigator's opinion, may affect patient safety or compliance. * Patients with suspected allergy to Gecacitinib Hydrochloride, interferon, or similar drugs. * Patients with active alcohol or drug addiction that would interfere with their ability to comply with study requirements. * Patients who have participated in another investigational new drug or medical device study and have received study drug or used study device within 12 weeks prior to screening. * Patients who have used any immunomodulators, any immunosuppressants, ≥10 mg/day prednisone or equivalent corticosteroids, or are within 6 half-lives of such medications within 2 weeks prior to enrollment, whichever is longer.