[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628095":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":11,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":11,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":11},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Golidocitinib + Pegaspargase + Anti-PD-1 mAb","EXPERIMENTAL",null,[13],"Drug: Golidocitinib + Pegaspargase + Anti-PD-1 mAb",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","* Golidocitinib: 150 mg orally, once daily, continuous administration.\n* Pegaspargase: 2000-2500 IU\u002Fm² intravenously, once every 3 weeks (Day 1 of each cycle).\n* Anti-PD-1 mAb: Administered per product labeling, once every 3 weeks (Day 1 of each cycle).\n* Treatment Cycle: 3 weeks per cycle; combined treatment for up to 6 cycles. Patients achieving response may receive maintenance therapy with golidocitinib and\u002For anti-PD-1 mAb for up to 24 months.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Liang Wang","CONTACT","+86 15001108693","wangliangtrhos@126.com",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","LIANG WANG","Chief physician","100628095","phase-2-phaes--study-of-golidocitinib-pegaspargase-pd-1-antibody-first-line-for-advanced-enktl-100628095",false,"NCT07457177","Phaes Ⅱ Study of Golidocitinib-Pegaspargase-PD-1 Antibody First-Line for Advanced ENKTL","A Single-Arm, Open-Label Phase II Clinical Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Pegaspargase and Anti-Programmed Death-1 (PD-1) Monoclonal Antibody as First-Line Therapy for Advanced Extranodal Natural Killer\u002FT-Cell Lymphoma (ENKTL)","Inclusion Criteria:\n\n1. Voluntarily provides written informed consent (ICF) and agrees to comply with study procedures.\n2. Histopathologically confirmed ENKTL per the 2022 WHO Classification of Lymphoid Neoplasms, with no prior systemic anti-lymphoma therapy.\n3. At least one measurable or evaluable lesion per 2014 Lugano Classification:\n\n   Measurable lesion: Lymph node ≥1.5 cm (long axis) × ≥1.0 cm (short axis); extranodal lesion ≥1.0 cm (long axis); if the only measurable lesion was previously irradiated, radiological progression after radiotherapy is required.\n\n   Evaluable lesion: FDG-PET uptake higher than liver in lymph nodes or extranodal sites, consistent with lymphoma.\n4. Age ≥18 years at ICF signing.\n5. Estimated life expectancy ≥12 weeks.\n6. ECOG performance status 0-2.\n\n   Adequate organ and bone marrow function (without supportive care within 14 days):\n7. Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL (≥0.5×10⁹\u002FL with bone marrow involvement); Platelet (PLT) ≥100×10⁹\u002FL (≥50×10⁹\u002FL with bone marrow involvement); Hemoglobin (HGB) ≥8.0 g\u002FdL.\n\n   Liver function: Total Bilirubin (TBIL) ≤1.5×ULN (≤3.0×ULN for Gilbert syndrome or liver involvement); Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN (≤5.0×ULN for liver involvement).\n\n   Renal function: Serum Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance Rate (Ccr) ≥50 mL\u002Fmin (Cockcroft-Gault method).\n\n   Coagulation: International Normalized Ratio (INR) ≤1.5×ULN; Prothrombin Time (PT)\u002FActivated Partial Thromboplastin Time (APTT) ≤1.5×ULN (unless on anticoagulants with stable levels).\n\n   Thyroid function: Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), Free Triiodothyronine (FT3) within ±10% of normal range (non-autoimmune TSH abnormalities allowed).\n8. Left Ventricular Ejection Fraction (LVEF) ≥50% by MUGA or echocardiogram.\n9. Resolution of acute toxicities from prior therapies to ≤Grade 1 (CTCAE v5.0) or baseline; irreversible Grade 2 toxicities (e.g., neuropathy, alopecia) are allowed if not worsening.\n10. Women of Childbearing Potential (WOCBP) must have negative serum pregnancy test within 7 days of first dose; WOCBP and male partners must use effective contraception from ICF signing to 6 months after last study drug dose.\n\nExclusion Criteria:\n\n1. Aggressive NK-cell leukemia or ENKTL in leukemic phase.\n2. Concurrent hemophagocytic syndrome.\n3. Lymphoma involvement of central nervous system (CNS) or meninges.\n4. History of other malignancies within 5 years (except cured localized tumors: e.g., basal\u002Fsquamous cell skin cancer, in situ prostate\u002Fcervical\u002Fbreast cancer).\n5. Prior therapy:\n\n   Allogeneic hematopoietic stem cell transplantation (HSCT) within 5 years (allowed if \\>5 years with no graft-versus-host disease).\n\n   Autologous HSCT within 3 months. Prior JAK\u002FSTAT3 inhibitors. Concurrent use of strong CYP3A inducers\u002Finhibitors (unable to discontinue 1 week before first dose).\n\n   Concurrent vitamin K antagonists, antiplatelet agents, or anticoagulants (unable to discontinue 1 week before first dose).\n\n   Systemic glucocorticoids or immunosuppressants within 14 days (local\u002Focular\u002Finhaled\u002Fnasal glucocorticoids or short-term ≤7 days for prophylaxis allowed).\n\n   Cytotoxic chemotherapy within 21 days. Systemic anti-tumor therapy (including mAbs, immunotherapy) within 4 weeks. Major surgery within 6 weeks or radiotherapy within 90 days. Toxin\u002Fisotope-antibody conjugates within 10 weeks. Investigational drugs within 30 days.\n\n   Active infections:\n\n   Active\u002Flatent tuberculosis (PPD positive with induration \\>10 mm or radiological evidence).\n\n   HIV infection. Active chronic hepatitis B (HBsAg positive with HBV DNA \\>2500 copies\u002FmL or 500 IU\u002FmL) or hepatitis C (HCV RNA positive). HBV carriers with controlled HBV DNA and cured HCV are allowed; HBsAg-positive patients require monthly HBV DNA monitoring and prophylactic entecavir until 12 months after anti-tumor therapy.\n6. Active viral infections (e.g., herpes zoster) or bacterial infections requiring IV\u002Foral antimicrobials within 30 days (including pneumonia).\n7. Active autoimmune diseases requiring systemic therapy within 2 years (allowed if inactive for 2 years; hormone replacement therapy for hypothyroidism\u002Fdiabetes is allowed).\n8. Uncontrolled cardiac disease: NYHA Class \\>2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmias requiring treatment.\n9. Prior interstitial lung disease (except radiation-induced asymptomatic disease).\n10. Unresolved Grade \\>1 AEs (except alopecia) from prior therapies.\n11. Hypersensitivity to golidocitinib, pegaspargase, anti-PD-1 mAb, or excipients; history of Grade ≥3 hypersensitivity to mAbs or uncontrolled allergic asthma.\n12. Refractory nausea\u002Fvomiting, chronic gastrointestinal disease, dysphagia, or prior bowel resection affecting drug absorption.\n13. Pregnant or lactating women; unwilling to use contraception.\n14. Psychiatric illness or inability to provide informed consent.\n15. Investigator-determined unsuitability for study participation.","ALL","18 Years",{"count":39,"type":40},40,"ESTIMATED","INTERVENTIONAL",[43],"PHASE2","Extranodal natural killer\u002FT-cell lymphoma (ENKTL) is an aggressive non-Hodgkin lymphoma with poor prognosis in advanced stages, with a 5-year overall survival (OS) rate of less than 30% despite asparaginase-based regimens. Preclinical and clinical evidence suggests that PD-L1 is highly expressed in ENKTL, and PD-1 inhibitors show promising activity, while JAK1 inhibitors (e.g., golidocitinib) can reverse PD-1\u002FPD-L1 inhibitor resistance and enhance anti-tumor immunity. This phase II study aims to evaluate the safety, tolerability, and anti-tumor activity of golidocitinib combined with pegaspargase and anti-PD-1 mAb as first-line therapy for advanced treatment-naive ENKTL, providing a novel therapeutic option for this patient population.",[46],"NK T-Cell Lymphoma","NOT_YET_RECRUITING","2026-03-03",{"date":50,"type":51},"2026-03-09","ACTUAL",{"date":53,"type":40},"2026-02-10",{"date":55,"type":40},"2030-01-30",{"name":27,"class":6}]