Actively Recruiting
A Multicenter, Phase 3, Randomized Trial of Sequential Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type
Led by Sun Yat-sen University · Updated on 2025-03-13
207
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of sequential chemoradiotherapy with or without the addition of toripalimab, a PD-1 antibody, in people newly diagnosed with early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL). This phase 3, randomized, multi-center clinical trial aims to compare these two treatment approaches to better understand their impact on this specific lymphoma type. Participants are assigned to one of two groups. One group receives toripalimab combined with induction chemotherapy using pegaspargase, gemcitabine, and oxaliplatin every three weeks for four cycles prior to radiation. They then receive intensity-modulated radiotherapy (IMRT) and continue toripalimab every three weeks during and after radiation for a total of 13 cycles. The other group receives the same chemotherapy and radiation schedule without toripalimab. Throughout the study, participants undergo regular evaluations to monitor treatment response and safety. Researchers will measure progression-free survival over three years as the primary outcome. Secondary outcomes include complete remission rate, overall response rate, overall survival, recurrence-free survival, event-free survival, and disease-free survival, all tracked up to three years or six months as appropriate. The study follows participants from the start of treatment through multiple years to assess long-term outcomes.
CONDITIONS
Brief Title
A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy confirmed extranodal natural killer/T-cell lymphoma, nasal type
- Newly diagnosed stage I or II patients
- At least one measurable lesion
- ECOG performance status 0 to 2
- Aged 18 to 75 years
- No other malignancies
- Proper functioning of major organs
You will not qualify if you...
- Hemophagocytic syndrome or aggressive NK cell leukemia
- Central nervous system involvement
- Previous treatment with chemotherapy, radiotherapy, immunotherapy, or biotherapy for lymphoma
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.
1 visit (in-person)
Duration - Approximately 9 to 12 months depending on the number of toripalimab cycles administered
Participants receive induction chemotherapy every 3 weeks for 4 cycles followed by definitive intensity-modulated radiotherapy (IMRT) over 25 to 26 days. Participants in the experimental arm also receive toripalimab every 3 weeks before and during radiotherapy, continuing up to 13 cycles.
Multiple visits every 3 weeks during chemotherapy and toripalimab treatment, daily visits during radiotherapy for 25 to 26 days
Trial Site Locations
Total: 1 location
1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qingqing Cai, MD
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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