Actively Recruiting
A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2026-04-24
142
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
CONDITIONS
Official Title
A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age between 18 and 70 years, male or non-pregnant female
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO type II or III)
- Stage III disease or pre-treatment plasma Epstein-Barr virus DNA 61500 copies/ml
- Complete or partial response after 3 cycles of induction immunochemotherapy
- ECOG performance status score of 0 or 1
- Adequate blood function: Hemoglobin 690g/L, White Blood Cell count 6.0x10^9/L, Platelets 60.0x10^9/L
- Adequate liver function: ALT and AST 62.5 times upper limit of normal, total bilirubin 62.0 times upper limit of normal, serum albumin 630g/L
- Adequate kidney function: Serum creatinine 1.5 times upper limit of normal or creatinine clearance 60 mL/min
- Coagulation parameters (INR and APTT) 61.5 times upper limit of normal unless on anticoagulants with therapeutic range
You will not qualify if you...
- Recurrent or distant metastatic nasopharyngeal carcinoma
- Keratinizing squamous cell carcinoma (WHO type I)
- Prior radiotherapy or systemic chemotherapy
- Pregnant or breastfeeding women, or those not using effective contraception
- HIV positive
- History of other malignancies except cured basal cell carcinoma or cervical carcinoma in situ
- Prior treatment with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors)
- Immunodeficiency diseases or organ transplant history
- Autoimmune diseases including myasthenia gravis, myositis, autoimmune hepatitis, lupus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis with antiphospholipid syndrome, Wegener's granulomatosis, Sj�f6gren's syndrome, Guillain-Barr�e9 syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Recent use (within 4 weeks) of high-dose glucocorticoids, anticancer monoclonal antibodies, or immunosuppressive therapy
- Significant impairment of heart, liver, lung, kidney, or bone marrow function
- Severe uncontrolled medical conditions or infections
- Concurrent use of other investigational drugs or participation in another clinical trial
- Refusal or inability to sign informed consent
- Any other contraindications to treatment
- Personality or psychiatric disorders or limited legal capacity
- Hepatitis B surface antigen positive with HBV DNA 61000 copies/ml unless stable chronic hepatitis B
- Positive hepatitis C antibody unless PCR test for HCV RNA is negative
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
P
Pei-Yu Huang
CONTACT
Q
Qi Yang
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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