Actively Recruiting
Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial
Led by Jiangxi Provincial Cancer Hospital · Updated on 2026-05-15
264
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating maintenance therapies for patients with high-risk nasopharyngeal carcinoma characterized by N3 classification, rENE positivity, or detectable EBV DNA after induction chemotherapy. This phase III clinical trial aims to compare whether combining toripalimab with capecitabine offers better outcomes than capecitabine alone for these patients. Participants are randomly assigned to one of two groups: one receiving maintenance therapy with both toripalimab and capecitabine, and the other receiving only capecitabine. Capecitabine is given orally twice daily for 14 days every 3 weeks, while toripalimab is administered every 3 weeks. Both treatments continue for a total of 12 months. Throughout the study, participants undergo regular monitoring to assess disease progression and survival over three years. The primary measurement is progression-free survival at 3 years, with additional evaluations including distant metastasis-free survival, overall survival, and loco-regional recurrence-free survival. Patients will be assessed for safety and treatment adherence during their participation, which may last several years including long-term follow-up.
CONDITIONS
Brief Title
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed nasopharyngeal carcinoma
- High-risk nasopharyngeal cancer meeting at least one of: TanyN3M0; high-grade rENE with coalescent nodal or invasion of surrounding structures; detectable EBV DNA after 2 cycles of induction chemotherapy
- Age between 18 and 70 years, any gender
- ECOG performance status of 0 or 1
- Completed 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy
- Adequate organ function without recent blood transfusions or growth factor support
- Negative pregnancy test for women with fertility potential
- Provided written informed consent
You will not qualify if you...
- Recurrent or distant metastatic nasopharyngeal carcinoma
- History of malignant tumors within last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Prior radiotherapy or systemic anti-cancer therapy for nasopharyngeal carcinoma
- Prior treatment with anti-PD-1 monoclonal antibody
- Active or relapsing autoimmune diseases (except controlled conditions as specified)
- Recent systemic corticosteroid or immunosuppressive treatments above specified doses
- History of interstitial lung disease or uncontrolled lung diseases
- Severe or active infections requiring systemic treatment
- Known HIV infection
- Untreated or active hepatitis B or C with high viral loads
- Major surgery within 28 days before study start
- Prior allogeneic stem cell or organ transplantation
- Significant cardiovascular risks or recent serious cardiac events
- Severe hypersensitivity to study drugs or excipients
- Use of herbal medicine for cancer control within 14 days before study
- Unresolved toxicities from prior cancer therapies
- Concurrent participation in another therapeutic clinical study
- Emotional disturbance or mental illness
- Refusal or inability to sign informed consent
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 - 12 months
Participants receive maintenance therapy with either toripalimab combined with capecitabine or capecitabine alone for high-risk nasopharyngeal carcinoma.
Visits every 3 weeks during maintenance therapy
Trial Site Locations
Total: 3 locations
1
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China, 341000
Not Yet Recruiting
2
First Affiliated hospital of Gannan Medical University
Guangzhou, Jiangxi, China, 341000
Actively Recruiting
3
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, None Selected, China, 330029
Actively Recruiting
Research Team
J
Jingao Li, MD
X
Xiaochang Gong, 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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