[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622620":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Golidocitinib + P-GemOx + PD-1 Inhibitor","EXPERIMENTAL","Golidocitinib (150 mg orally once daily, Days 1-21) Pegaspargase (2000 U\u002Fm² intravenously, Day 2) Gemcitabine (1000 mg\u002Fm² intravenously, Day 1) Oxaliplatin (100 mg\u002Fm² intravenously, Day 1) PD-1 inhibitor (200 mg intravenously, Day 1) Participants receive 6 cycles of induction therapy; those achieving complete response (CR) or partial response (PR) will continue maintenance therapy (Golidocitinib + PD-1 inhibitor, same dosage\u002Fschedule) for 1 year or until disease progression.",[13],"Drug: Golidocitinib in combination with P-GEMOX and PD-1 inhibitor",{"label":15,"type":16,"description":17,"interventionNames":18},"P-GemOx + PD-1 Inhibitor","ACTIVE_COMPARATOR","Pegaspargase (2000 U\u002Fm² intravenously, Day 2) Gemcitabine (1000 mg\u002Fm² intravenously, Day 1) Oxaliplatin (100 mg\u002Fm² intravenously, Day 1) PD-1 inhibitor (200 mg intravenously, Day 1) Participants receive 6 cycles of induction therapy; those achieving complete response (CR) or partial response (PR) will continue maintenance therapy (PD-1 inhibitor alone, same dosage\u002Fschedule) for 1 year or until disease progression.",[19],"Drug: PD-1 inhibitor in combination with P-GEMOX",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Golidocitinib in combination with P-GEMOX and PD-1 inhibitor","Participants receive this combination for 6 cycles of induction therapy. Those achieving complete response (CR) or partial response (PR) post-induction will continue maintenance therapy with golidocitinib plus PD-1 inhibitor (same dosage and administration schedule) for 1 year, or until disease progression, unacceptable toxicity, or voluntary withdrawal from the study. This regimen is designed to target the STAT3 signaling pathway (via golidocitinib) while combining cytotoxic chemotherapy (P-GEMOX) and immune checkpoint inhibition (PD-1 inhibitor) for synergistic anti-lymphoma activity.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PD-1 inhibitor in combination with P-GEMOX","Participants receive this combined regimen for 6 cycles of induction therapy. For those achieving complete response (CR) or partial response (PR) post-induction, maintenance therapy is continued with PD-1 inhibitor alone (same 200 mg intravenous dose on Day 1 of each 21-day cycle) for 1 year, or until disease progression, unacceptable treatment-related toxicity, or study discontinuation. This regimen represents a currently established first-line therapeutic option for advanced\u002Fnon-nasal ENKTL, serving as the active comparator for evaluating the added benefit of golidocitinib in the experimental arm.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Wei Xu","CONTACT","13951699449","xuwei10000@hotmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","WEI XU","Chief Physician, Department of Hematology","100622620","phase-2-golidocitinib-combined-with-p-gemox-plus-pd-1-inhibitor-versus-p-gemox-plus-pd-1-inhibitor-in-first-line-newly-diagnosed-advanced-or-non-nasal-extranodal-nkt-cell-lymphoma-100622620",false,"NCT07385989","Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in First-Line Newly Diagnosed Advanced or Non-Nasal Extranodal NK\u002FT-Cell Lymphoma","A Randomized Controlled Multicenter Phase 2 Clinical Trial of Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in the Treatment of First-Line Newly Diagnosed Advanced Extranodal NK\u002FT-Cell Lymphoma (ENKTL) or Non-Nasal Extranodal NK\u002FT-Cell Lymphoma (ENKTL)","Inclusion Criteria:\n\n1. Voluntarily provides written informed consent (ICF) prior to any study procedures.\n2. Aged 18-70 years (inclusive), regardless of sex.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed extranodal NK\u002FT-cell lymphoma (ENKTL), staged as Stage III-IV or non-nasal ENKTL (per 2016 WHO Classification of Hematopoietic and Lymphoid Tumors).\n5. At least one measurable\u002Fevaluable lesion (per 2014 Lugano Classification: measurable lesion ≥1.5 cm in longest diameter + ≥1.0 cm in shortest diameter; evaluable lesion with FDG uptake higher than liver on PET\u002FCT).\n6. Treatment-naive (no prior anti-cancer therapy for ENKTL).\n7. Adequate organ function:\n\n   AST\u002FALT ≤2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine \\\u003C1.5×ULN or creatinine clearance (CrCl, via Cockcroft-Gault formula) ≥60 mL\u002Fmin.\n8. Reproductive-aged females have a negative pregnancy test at screening; all participants use effective contraception during the study and for 12 months after the last dose.\n9. Expected survival ≥6 months.\n\nExclusion Criteria:\n\n1. Complicated by hemophagocytic lymphohistiocytosis (HLH) or aggressive NK-cell leukemia.\n2. Contraindication to golidocitinib, PD-1 inhibitor, or any component of the P-GEMOX regimen.\n3. Lymphoma involvement of the central nervous system (CNS).\n4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to study treatment initiation.\n5. History of other malignant tumors (except curatively treated in situ cancers, e.g., cervical carcinoma in situ) within 5 years.\n6. Uncontrolled severe comorbidities (e.g., NYHA Class II+ heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmias).\n7. Active bleeding (e.g., gastrointestinal hemorrhage, cerebral hemorrhage).\n8. Uncontrolled infection (requiring parenteral anti-infective therapy) within 7 days prior to study treatment.\n9. Active hepatitis B\u002FC: HBsAg+\u002FHBcAb+ with HBV-DNA \\>2500 copies\u002FmL (or 500 IU\u002FmL); HCV antibody+ with positive HCV-RNA.\n10. HIV infection or acquired immunodeficiency syndrome (AIDS).\n11. Conditions impairing drug absorption (e.g., inability to swallow tablets, malabsorption syndrome).\n12. Pregnant\u002Flactating females, or reproductive-aged participants refusing contraception.\n13. Psychiatric illness precluding informed consent or study compliance.\n14. Other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years","70 Years",{"count":52,"type":53},40,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","This is a multicenter, randomized, Phase 2 clinical trial designed to evaluate the efficacy and safety of golidocitinib combined with the P-GemOx (pegaspargase + gemcitabine + oxaliplatin) regimen plus PD-1 inhibitor, compared with P-GemOx plus PD-1 inhibitor alone, in participants with first-line newly diagnosed advanced (Stage III-IV) or non-nasal extranodal natural killer\u002FT-cell lymphoma (ENKTL). Eligible participants will be randomly assigned 1:1 to two groups:\n\nExperimental group: Golidocitinib (150 mg orally once daily, Days 1-21 per 21-day cycle) + P-GemOx (pegaspargase 2000 U\u002Fm² on Day 2; gemcitabine 1000 mg\u002Fm² on Day 1; oxaliplatin 100 mg\u002Fm² on Day 1, per 21-day cycle) + PD-1 inhibitor (200 mg intravenously on Day 1 per 21-day cycle).\n\nControl group: P-GemOx + PD-1 inhibitor (same dosage\u002Fschedule as the experimental group, without golidocitinib). All participants will receive 6 cycles of induction therapy. Those achieving CR or partial response (PR) after induction will receive maintenance therapy for 1 year: the experimental group will continue golidocitinib + PD-1 inhibitor, while the control group will receive PD-1 inhibitor alone (both per 21-day cycles). The primary outcome is the complete response rate (CRR) after 6 induction cycles (assessed per the 2014 Lugano Classification for Lymphoma). Secondary outcomes include overall response rate (ORR), 2-year progression-free survival (PFS), 2-year overall survival (OS), and the incidence of treatment-related adverse events (graded per NCI-CTCAE Version 5.0). 40 participants will be enrolled across multiple Chinese medical centers. This Phase 2 trial will provide preliminary evidence to determine whether the golidocitinib combination regimen is a safe and effective first-line option for advanced or non-nasal ENKTL.",[59],"Extranodal NK\u002FT-cell Lymphoma","NOT_YET_RECRUITING","2026-01-27",{"date":63,"type":64},"2026-02-04","ACTUAL",{"date":66,"type":53},"2026-01-25",{"date":68,"type":53},"2032-12-31",{"name":39,"class":6}]