Actively Recruiting
Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial
Led by Sun Yat-sen University · Updated on 2025-11-25
802
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adaptive immunotherapy strategies for patients with locoregionally advanced nasopharyngeal carcinoma (NPC). The study aims to compare whether radiotherapy alone is no worse than combined chemoradiotherapy in low-risk patients who respond well to initial treatment and have undetectable Epstein-Barr virus (EBV) DNA in their blood. For high-risk patients with stable disease or detectable EBV DNA after induction therapy, the study assesses whether adding capecitabine and immunotherapy after chemoradiotherapy improves event-free survival. The trial includes four treatment groups: low-risk patients receive either radiotherapy alone or concurrent chemoradiotherapy; high-risk patients receive either adjuvant capecitabine plus immunotherapy or immunotherapy alone following concurrent chemoradiotherapy. Capecitabine is given as a metronomic dose of 650 mg/m² twice daily for one year. Immunotherapy with Toripalimab is administered every three weeks. Induction chemoimmunotherapy is completed before randomization. The study is a randomized, controlled, multicenter phase 3 trial. Participants will be monitored for event-free survival and treatment-related nausea over three years. Assessments include overall survival, relapse-free survival, distant metastasis-free survival, adverse event monitoring, and quality-of-life evaluations using standardized questionnaires. Safety and treatment tolerability are regularly assessed. The total study duration includes treatment and follow-up periods extending up to three years to capture long-term outcomes and side effects.
CONDITIONS
Brief Title
Adaptive Immunotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Newly diagnosed, pathologically confirmed non-keratinizing carcinoma
- Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) per AJCC 9th edition
- ECOG performance status of 0 or 1
- Adequate bone marrow function: WBC > 4 x 10^9/L, hemoglobin > 90 g/L, platelets > 100 x 10^9/L
- Normal renal and liver function within specified limits
- Normal thyroid, amylase, lipase, and pituitary function
- Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy
- Signed informed consent and willingness to comply with study procedures
- Female participants of childbearing potential must use reliable contraception from screening until one year after treatment
You will not qualify if you...
- T3N0-1 stage according to AJCC 9th edition
- Disease progression after induction therapy
- Positive hepatitis B surface antigen with high HBV DNA or positive hepatitis C antibody
- Positive HIV antibody or diagnosis of AIDS
- Active tuberculosis
- Active, known, or suspected autoimmune diseases except certain exceptions
- History of interstitial lung disease or pneumonia requiring steroids within the past year
- Current chronic systemic glucocorticoid or immunosuppressive therapy
- Uncontrolled cardiac disease
- Pregnant or breastfeeding women
- History or current diagnosis of other malignancies except specific treated cancers
- Known allergy to macromolecular protein preparations or toripalimab components
- Active infection needing systemic treatment within one week before enrollment
- Recent live vaccine administration within 30 days before first toripalimab dose
- History of organ transplantation
- Contraindications to MRI
- Any condition deemed unsafe or non-compliant by investigators
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 - Up to 1 year for adjuvant treatment; concurrent chemoradiotherapy and radiotherapy durations vary accordingly
Participants receive treatment based on their risk group. Low-risk participants receive either radiotherapy alone or concurrent chemoradiotherapy. High-risk participants receive concurrent chemoradiotherapy followed by adjuvant capecitabine and immunotherapy or adjuvant immunotherapy alone.
Multiple visits during radiotherapy and concurrent chemoradiotherapy; regular visits for adjuvant capecitabine and immunotherapy up to one year
Duration - Up to 3 years
Participants are monitored for event-free survival, adverse events, quality of life, and other outcomes for up to 3 years after treatment.
Periodic follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
L
Ling-Long Tang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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