Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Na
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
| Condition(s) | Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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/ |
| Who can participate | Inclusion Criteria: 1. Pathologically diagnosed with ENKTL. 2. Advanced stage. 3. Has at least one measurable or assessable lesion. 4. Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months. 5. Willing to participate in the clinical study; fully informed and has signed a written informed consent form. 6. Adequate organ and bone marrow function. Exclusion Criteria: 1. Aggressive NK-cell leukemia. 2. Central nervous system involvement. 3. Patients with significant dysfunction of vital organs. 4. History of allergy to the investigational drug, similar drugs, or excipients. 5. Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes). 6. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use cont |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2024-10-22 |
| NCT ID | NCT06583083 |
| Official listing | https://clinicaltrials.gov/study/NCT06583083 |