Actively Recruiting
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
Led by Sun Yat-sen University · Updated on 2026-04-14
84
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed with extranodal NK/T-cell lymphoma (ENKTL).
- Advanced stage disease.
- At least one measurable or assessable lesion.
- Age over 18 years with an expected survival of more than 3 months.
- Willing to participate with full informed consent.
- Adequate organ and bone marrow function.
You will not qualify if you...
- Aggressive NK-cell leukemia.
- Central nervous system involvement.
- Significant dysfunction of vital organs.
- History of allergy to the investigational drug, similar drugs, or excipients.
- Major organ surgery within the last 6 weeks, except biopsy.
- Pregnant or breastfeeding women, and women of childbearing potential unwilling to use contraception.
- Active infection, excluding tumor-related fever.
- Known HIV infection or AIDS.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
C
Cai Qingqing, MD.PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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