Actively Recruiting
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Led by Sun Yat-sen University · Updated on 2026-05-11
212
Participants Needed
12
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
CONDITIONS
Official Title
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with local or regional recurrent nasopharyngeal carcinoma at least 1 year after radical treatment
- Not suitable for surgery
- Histologic diagnosis of nasopharyngeal carcinoma (WHO II/III)
- TNM stage rII-IVa according to AJCC/UICC 8th edition
- ECOG performance status 0-1
- No prior treatment for recurrent nasopharyngeal carcinoma including radiotherapy, chemotherapy, immunotherapy, or biotherapy
- No contraindications to immunotherapy or chemoradiotherapy
- Adequate marrow function: WBC count 2 3x10^9/L, neutrophil count 2 1.5x10^9/L, hemoglobin 2 90 g/L, platelet count 2 100x10^9/L
- Adequate liver function: ALT/AST 2 2.5x upper limit of normal, total bilirubin 2 2.0x upper limit of normal
- Adequate renal function: BUN/creatinine 2 1.5x upper limit of normal or creatinine clearance 2 60 ml/min (Cockcroft-Gault formula)
- Use effective contraception during treatment and for two months after
- Provide written informed consent after being informed about the investigational nature of the study
You will not qualify if you...
- Treated with anti-tumor Chinese medicine
- Recurrence with local necrosis
- Grade 3 or higher late toxicities except skin, subcutaneous tissue, or mucosa
- Unexplained fever over 38.5C except tumor-related fever
- Treated with 5 or more days of antibiotics within one month before enrollment
- Active autoimmune disease such as uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, or asthma requiring bronchodilators
- Known HIV infection, active Hepatitis B (HBV-DNA 2 10^3 copies/ml), or positive Hepatitis C antibody
- Previous treatment with PD-1 antibody or other immunotherapy targeting PD-1/PD-L1
- New York Heart Association class 3 or 4 heart failure, unstable angina, myocardial infarction within 1 year, or treatment-requiring arrhythmia
- Allergy to large molecule protein products or any component of study therapy
- Pregnant or breastfeeding
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, or papillary thyroid carcinoma
- Received live vaccine within 30 days before planned study therapy
- Psychiatric drug or substance abuse disorders interfering with study cooperation
- Any other condition or factor deemed by the investigator to interfere with consent, participation, or result interpretation
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Peking University Third Hospital
Beijing, China
Actively Recruiting
3
Sichuan Cancer Hospital
Chengdu, China
Not Yet Recruiting
4
Fujian Province Cancer Hospital
Fuzhou, China
Not Yet Recruiting
5
Guizhou Cancer Hospital
Guiyang, China
Not Yet Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
7
Jiangxi Cancer Hospital
Nanchang, China
Actively Recruiting
8
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Actively Recruiting
9
Fudan University Shanghai Cancer Center
Shanghai, China
Not Yet Recruiting
10
Zhongnan Hospital of Wuhan University
Wuhan, China
Actively Recruiting
11
Xijing Hospital
Xi'an, China
Actively Recruiting
12
The First Affiliated Hospital of Xiamen University
Xiamen, China
Not Yet Recruiting
Research Team
J
Jingjing Miao, PhD
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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