Actively Recruiting
Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy
Led by Ming-Yuan Chen · Updated on 2026-01-09
456
Participants Needed
12
Research Sites
345 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response \[CR\]/partial response \[PR\] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.
CONDITIONS
Official Title
Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO Type II or III).
- Clinical stage IIIa nasopharyngeal carcinoma as defined by AJCC 8th or 9th edition.
- Achieved partial or complete response after 3 cycles of platinum-based chemotherapy combined with immunotherapy induction, with EBV DNA reduced to zero or below detection.
- Age between 18 and 70 years.
- Performance status score of 0 or 1 (PS/ECOG).
- Adequate organ function including blood counts, liver and kidney function, and coagulation within specified limits.
- Signed informed consent and willingness to comply with study procedures.
You will not qualify if you...
- Laboratory test results within 7 days before enrollment not meeting required standards.
- Stable disease or progressive disease after induction treatment or EBV DNA not reduced to zero.
- Prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic) for primary or metastatic lesions.
- Tumors with liquefaction necrosis unsuitable for radiotherapy.
- Tumor invasion into brain tissue.
- History of severe allergies to monoclonal antibodies or PD-1/PD-L1 antibodies.
- Known or suspected autoimmune diseases including dementia and epilepsy.
- Recurrence, distant metastasis, or other concurrent malignant tumors.
- Severe heart or lung disease with function grade 3 or lower.
- Previous use of immune checkpoint inhibitors or related antibodies.
- Use of immunosuppressive drugs or corticosteroids before enrollment.
- Positive for HIV, active hepatitis B or C infection.
- Allergic reactions to study drugs like gemcitabine, docetaxel, taxanes, or cisplatin.
- Active tuberculosis or recent anti-tuberculosis treatment.
- Use of systemic glucocorticoids, anti-infective vaccines, or anti-tumor traditional medicines within 4 weeks before enrollment.
- Positive pregnancy test or lactating women.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 516000
Actively Recruiting
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
3
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
Actively Recruiting
4
The Second Affiliated Hospital of Sun Yat-sen University (SYSU)
Guangzhou, Guangdong, China
Actively Recruiting
5
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Actively Recruiting
6
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
Actively Recruiting
7
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Actively Recruiting
8
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Actively Recruiting
9
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
10
Central South University Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
11
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
12
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangdong, Zhuhai, China, 519000
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD,PhD
CONTACT
R
Rui You, MD,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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