Actively Recruiting
A Multicenter, Phase 2, Randomized Trial of Sintilimab (PD-1 Antibody) With P-GEMOX Versus the P-GEMOX Regimen in the Treatment of Newly Diagnosed Advanced-stage Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (SPIRIT-02)
Led by Sun Yat-sen University · Updated on 2026-04-14
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for advanced extranodal natural killer/T-cell lymphoma (ENKTL), a rare and aggressive type of non-Hodgkin lymphoma with poor prognosis in advanced stages. This phase 2 randomized trial aims to assess the effectiveness and safety of combining sintilimab, a PD-1 antibody, with chemotherapy compared to chemotherapy alone as a first-line treatment. The study also investigates biomarkers that might predict patient responses, potentially offering new therapeutic options for ENKTL patients. The trial compares two treatment groups: one receives sintilimab intravenously combined with the P-GEMOX chemotherapy regimen, which includes pegaspargase (intramuscular injection), gemcitabine, and oxaliplatin (both intravenous drips). The other group receives the P-GEMOX regimen alone. This study involves multiple centers and follows patients under these treatments to evaluate outcomes over time. Participants must be adults with newly diagnosed advanced ENKTL and at least one measurable lesion. They will be monitored for progression-free survival up to four years as the primary outcome, alongside secondary outcomes such as overall response, complete remission, overall survival, and adverse events. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study duration, with informed consent and eligibility confirmed before enrollment.
CONDITIONS
Brief 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 natural killer/T-cell lymphoma (ENKTL)
- Advanced stage disease
- At least one measurable or assessable lesion
- Age over 18 years with no gender restrictions
- Expected survival of more than 3 months
- Willing to participate and has signed 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
- Allergy to the investigational drug, similar drugs, or excipients
- Less than 6 weeks since major organ surgery (excluding biopsy)
- Pregnant or breastfeeding women or women unwilling to use contraception
- Active infection, excluding fever related to tumor-associated symptoms
- Known HIV infection or AIDS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 years
Participants receive either Sintilimab with P-GEMOX regimen or P-GEMOX regimen as drug treatments for advanced-stage extranodal natural killer/T cell lymphoma.
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
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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