Actively Recruiting
PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients
Led by Sun Yat-sen University · Updated on 2026-05-07
212
Participants Needed
12
Research Sites
456 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
CONDITIONS
Official Title
PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with local or regional recurrence of nasopharyngeal carcinoma at least 1 year after radical treatment
- Not suitable for surgery
- Newly diagnosed histologic nasopharyngeal carcinoma (WHO II/III)
- Clinical stage rII-IVa as per AJCC/UICC 8th edition
- ECOG performance status of 0 or 1
- No prior treatment for recurrent nasopharyngeal carcinoma including radiotherapy, chemotherapy, immunotherapy, or biotherapy
- No contraindications to immunotherapy or radiotherapy
- Adequate marrow function: WBC 3x10^9/L, neutrophils 1.5x10^9/L, hemoglobin 90 g/L, platelets 100x10^9/L
- Adequate liver function: ALT/AST 2.5 times upper limit of normal, total bilirubin 2 times upper limit of normal
- Adequate renal function: BUN/creatinine 1.5 times upper limit of normal or creatinine clearance 60 ml/min
- Use effective contraception during treatment and for two months after
- Provide written informed consent
You will not qualify if you...
- Treated with anti-tumor Chinese medicine
- Presence of local necrosis at recurrence
- Grade 3 or higher late toxicities except for skin, subcutaneous tissue, or mucosa
- Unexplained fever above 38.5 6C not due to tumor
- Use of antibiotics for 5 or more days within one month before enrollment
- Active autoimmune diseases such as uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, or asthma requiring bronchodilators
- Known HIV infection, active hepatitis B or C infection
- Prior treatment with PD-1 antibody or other immunotherapy targeting PD-1/PD-L1 pathway
- NYHA class 3 or 4 heart failure, unstable angina, recent myocardial infarction within 1 year, or significant arrhythmia needing treatment
- Known allergy to large molecule protein products or study treatment compounds
- Pregnant or breastfeeding
- Previous malignancies except treated non-melanoma skin cancer, in situ cervical cancer, or papillary thyroid carcinoma
- Received live vaccine within 30 days before study start
- Psychiatric or substance abuse disorders interfering with study participation
- Any other condition likely to affect informed consent, cooperation, participation, or result interpretation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Peking University Third Hospital
Beijing, China
Not Yet 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
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, China
Not Yet Recruiting
7
Jiangxi Cancer Hospital
Nanchang, China
Not Yet 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
CONTACT
C
Chong Zhao
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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