Overview
Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.
Eligibility
Inclusion Criteria:
- Pathologically diagnosed with ENKTL.
- Advanced stage.
- Has at least one measurable or assessable lesion.
- Age > 18 years, no gender restrictions, with an expected survival of more than 3 months.
- Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
- Adequate organ and bone marrow function.
Exclusion Criteria:
- Aggressive NK-cell leukemia.
- Central nervous system involvement.
- Patients with significant dysfunction of vital organs.
- History of allergy to the investigational drug, similar drugs, or excipients.
- Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
- Active infection, excluding fever related to tumor-associated B symptoms.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).