Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural K… (NCT06583083) | Clinical Trial Compass
RecruitingPhase 2
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
China84 participantsStarted 2024-10-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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).