Actively Recruiting
Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2026-03-17
243
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
CONDITIONS
Official Title
Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or non-pregnant female
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO type II or III)
- Stage Any T, N2-3 or T4, N1 (AJCC 9th edition) with no distant metastasis (M0)
- ECOG performance status score of 0 or 1
- Adequate blood counts: Hemoglobin 60;90g/L, Absolute Neutrophil Count 60;1.5�D710�B9/L, Platelets 60;100�D710�B9/L
- Adequate liver function: ALT and AST 60;2.5 times upper limit of normal, total bilirubin 60;2.0 times upper limit of normal, serum albumin 60;30g/L
- Adequate kidney function: Serum creatinine 64;1.5 times upper limit of normal or creatinine clearance 60;60 mL/min
- INR and APTT 64;1.5 times upper limit of normal unless on anticoagulant therapy with expected range
You will not qualify if you...
- Recurrence or distant metastasis of nasopharyngeal carcinoma
- Diagnosis of keratinizing squamous cell carcinoma (WHO Type I)
- Prior radiotherapy or systemic chemotherapy
- Pregnant, lactating, or women of childbearing potential not using effective contraception
- HIV positive
- History of other cancers except cured basal cell carcinoma or carcinoma in situ of the cervix
- Previous treatment with immune checkpoint inhibitors
- Immunodeficiency or history of organ transplantation
- Use of high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks
- Significant impairment of heart, liver, lung, kidney, or bone marrow function
- Participation in other clinical trials or use of other investigational drugs
- Unable or unwilling to provide informed consent
- Personality or psychiatric disorders or limited legal capacity
- Positive hepatitis B with HBV DNA 60;1000 copies/ml
- Positive hepatitis C antibody with detectable HCV RNA
- Arterial or venous thrombosis within 6 months
- Known active tuberculosis or suspected active TB
- Any other severe uncontrolled medical condition or infection that may pose risks or interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Dongguan People's Hospital
Dongguan, Guangdong, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
3
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
Actively Recruiting
4
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Actively Recruiting
Research Team
H
Hai-Qiang Mai, Dr.
CONTACT
L
Li-Ting Liu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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