Actively Recruiting
PD-1 Antibody Combined With Chemoradiotherapy vs Chemoradiotherapy Alone in Recurrent Nasopharyngeal Carcinoma Patients: A Multicenter Randomized Controlled Phase III Trial
Led by Sun Yat-sen University · Updated on 2026-05-07
212
Participants Needed
12
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combining a PD-1 antibody with chemoradiotherapy compared to chemoradiotherapy alone in patients with recurrent nasopharyngeal carcinoma. This multicenter, randomized phase III clinical trial aims to assess both the effectiveness and side effects of these treatments in this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive three cycles of the PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, followed by intensity-modulated radiation therapy (IMRT) and maintenance PD-1 antibody for eight cycles. The other group will receive three cycles of GP chemotherapy followed by IMRT alone. Throughout the study, participants will be monitored for overall survival over three years, progression-free survival, short-term treatment effects, rates of acute toxicities, and quality of life using the EuroQoL 5 dimension questionnaire. The study involves ongoing assessments including physical exams, laboratory tests, and safety monitoring. The total duration includes treatment and follow-up periods extending up to three years.
CONDITIONS
Brief 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 one year after radical treatment
- Not suitable for surgery
- Newly confirmed histologic diagnosis of nasopharyngeal carcinoma (WHO II/III)
- Clinical stage rII-IVa according to AJCC/UICC 8th edition
- ECOG performance status of 0 or 1
- No prior treatment for recurrent nasopharyngeal carcinoma such as radiotherapy, chemotherapy, immunotherapy, or biotherapy
- No contraindications to immunotherapy or radiotherapy
- Adequate marrow function with specified blood counts
- Adequate liver function with ALT/AST and bilirubin within set limits
- Adequate renal function with BUN/creatinine or creatinine clearance within set limits
- Use effective contraception during and for two months after treatment
- Provided written informed consent after being informed about 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 for skin, subcutaneous tissue, or mucosa
- Unexplained fever above 38.5°C except tumor-related fever
- Antibiotic treatment for 5 or more days within one month before enrollment
- Active autoimmune diseases or history of HIV, active hepatitis B or positive hepatitis C antibody
- Previous treatment with PD-1 antibody or other PD-1/PD-L1 immunotherapy
- Severe heart conditions such as NYHA class 3 or 4 heart failure, unstable angina, recent myocardial infarction, or significant arrhythmia
- Known allergy to study treatment components
- Pregnant or breastfeeding
- Prior malignancy except certain treated skin, cervical, or thyroid cancers
- Received live vaccine within 30 days before planned treatment
- Psychiatric or substance abuse disorders interfering with study participation
- Any other condition likely to interfere with informed consent, cooperation, or result interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive chemoradiotherapy with or without PD-1 antibody. This includes three cycles of chemotherapy every three weeks, followed by intensity-modulated radiation therapy (IMRT). Participants in the experimental arm also receive PD-1 antibody maintenance for eight cycles.
Visits every 3 weeks for chemotherapy cycles, daily visits during radiation therapy, and regular visits during PD-1 antibody maintenance
Duration - Up to 3 years
Participants are monitored for overall survival, progression-free survival, acute toxicities, and quality of life for up to 3 years after treatment completion.
Regular follow-up visits during the 3-year period
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
C
Chong Zhao
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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