Actively Recruiting
Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response
Led by Sun Yat-sen University · Updated on 2026-03-06
593
Participants Needed
26
Research Sites
311 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.
CONDITIONS
Official Title
Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group performance status 1 or less
- Newly diagnosed, histologically confirmed non-keratinising nasopharyngeal carcinoma
- Tumor staged as Stage III (T3N0 excepted) according to AJCC 8th edition
- Lymph nodes without adverse features such as central necrosis, muscle or skin invasion, or lymph node fusion
- Normal bone marrow function: white blood cell count > 4 x 10^9/L, hemoglobin > 90 g/L, platelet count > 100 x 10^9/L
- Normal liver and kidney function: total bilirubin ≤ 1.5 times upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2.5 times upper limit of normal, alkaline phosphatase ≤ 2.5 times upper limit of normal, creatinine clearance rate ≥ 60 ml/min
- Received 3 cycles of induction chemotherapy with GP regimen plus Camrelizumab
- Plasma EBV DNA negative after second cycle of concurrent chemotherapy
- Complete remission after 27 fractions of radiotherapy confirmed by MRI
- Signed informed consent and willing to comply with study requirements
- Women of childbearing potential agree to use reliable contraception from screening until one year after treatment
You will not qualify if you...
- Positive for hepatitis B surface antigen with hepatitis B virus DNA over 1000 copies/ml
- Positive for hepatitis C virus antibodies
- Positive for HIV or diagnosed with AIDS
- Active tuberculosis within the past year or untreated past tuberculosis
- Active or suspected autoimmune diseases requiring systemic treatment, except some controlled conditions
- History of interstitial lung disease or pneumonia treated with steroids
- Chronic systemic glucocorticoid or immunosuppressive therapy (inhaled or topical corticosteroids allowed)
- Uncontrolled heart disease including heart failure (NYHA ≥ 2), unstable angina, recent myocardial infarction, or arrhythmias requiring treatment
- Active infections needing systemic treatment
- Previous or concurrent malignant tumors except treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary cancer
- Prior radiotherapy except for non-melanoma skin cancer outside nasopharyngeal radiation area
- Receiving treatments not specified in the research plan for local or regional disease
- Pregnant or lactating women
- Allergy to macromolecular protein preparations or Camrelizumab components
- Received live vaccine within 30 days before starting Camrelizumab
- Contraindications to MRI such as claustrophobia or allergy to MRI contrast
- History of psychotropic disease, alcoholism, drug abuse, or other conditions compromising safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
3
Dongguan People's Hospital
Dongguan, Guangdong, China
Actively Recruiting
4
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Actively Recruiting
5
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
6
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 511400
Actively Recruiting
7
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Actively Recruiting
8
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Actively Recruiting
9
Guangdong Nongken Central Hospital
Zhanjiang, Guangdong, China
Actively Recruiting
10
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
11
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
12
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Actively Recruiting
13
Hubei Province Cancer Hosiptal
Wuhan, Hubei, China
Actively Recruiting
14
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
15
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
16
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
17
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
18
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
19
Jiangsu Provinee Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Actively Recruiting
20
Jiangxi Cancer Center
Nanchang, Jiangxi, China
Actively Recruiting
21
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
Actively Recruiting
22
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
23
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
24
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
25
Chongqing Cancer Hospital
Chongqing, China
Actively Recruiting
26
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jun Ma
CONTACT
K
Kai-Bin Yang
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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