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/T-Cell Lymphoma
1. Voluntarily provides written informed consent (ICF) prior to any study procedures.
2. Aged 18-70 years (inclusive), regardless of sex.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed extranodal NK/T-cell lymphoma (ENKTL), staged as Stage III-IV or non-nasal ENKTL (per 2016 WHO Classification of Hematopoietic and Lymphoid Tumors).
5. At least one measurable/evaluable 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/CT).
6. Treatment-naive (no prior anti-cancer therapy for ENKTL).
7. Adequate organ function:
AST/ALT ≤2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine \<1.5×ULN or creatinine clearance (CrCl, via Cockcroft-Gault formula) ≥60 mL/min.
8. 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.
9. Expected survival ≥6 months.
You may not be if
1. Complicated by hemophagocytic lymphohistiocytosis (HLH) or aggressive NK-cell leukemia.
2. Contraindication to golidocitinib, PD-1 inhibitor, or any component of the P-GEMOX regimen.
3. Lymphoma involvement of the central nervous system (CNS).
4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to study treatment initiation.
5. History of other malignant tumors (except curatively treated in situ cancers, e.g., cervical carcinoma in situ) within 5 years.
6. Uncontrolled severe comorbidities (e.g., NYHA Class II+ heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmias).
7. Active bleeding (e.g., gastrointestinal hemorrhage, cerebral hemorrhage).
8. Uncontrolled infection (requiring parenteral anti-infective therapy) within 7 days prior to study treatment.
9. Active hepatitis B/C: HBsAg+/HBcAb+ with HBV-DNA \>2500 copies/mL (or 500 IU/mL); HCV antibody+ with positive HCV-RNA.
10. HIV infection or acquired immunodeficiency syndrome (AIDS).
11. Conditions impairing drug absorption (e.g., inability to swallow tablets, malabsorption syndrome).
12. Pregnant/lactating females, or reproductive-aged participants refusing contraception.
13. Psychiatric illness precluding informed consent or study compliance.
14. Other conditions deemed unsuitable for enrollment by the investigator.
Clareo Health | 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/T-Cell Lymphoma
