Actively Recruiting
Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer
Led by Ming-Yuan Chen · Updated on 2025-12-09
166
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
Sponsors
M
Ming-Yuan Chen
Lead Sponsor
F
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with/without CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of "immunotherapy combined with reduced-target radiotherapy" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.
CONDITIONS
Official Title
Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Signed informed consent and willingness to follow study procedures
- Newly diagnosed distant metastatic nasopharyngeal carcinoma patients with complete or partial response after first-line platinum-based chemotherapy and PD-1 monoclonal antibody
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III) with metastatic lesions detected by imaging
- Clinical stage TanyNanyM1, stage IVB according to AJCC 9th edition
- ECOG performance status of 0 or 1
- For women of childbearing potential, negative pregnancy test within 7 days before enrollment and agreement to use effective contraception during the study
- For men with female partners of reproductive potential, agreement to use effective contraception during the study
You will not qualify if you...
- Presence of malignant pleural effusion or other malignancies
- Previous receipt of two or more systemic therapy lines
- Known or suspected autoimmune diseases including dementia and seizures
- Grade 2 or higher coronary heart disease, arrhythmias including prolonged QTc interval, or heart failure
- Systemic or local glucocorticoid treatment within 4 weeks before enrollment
- Comorbidities requiring long-term immunosuppressive drugs or corticosteroids at immunosuppressive doses
- Active pulmonary tuberculosis or anti-TB treatment within 1 year before screening
- HIV positive status; positive HBsAg and high HBV DNA levels; positive hepatitis C antibody
- Any anti-infective vaccine within 4 weeks before enrollment
- Expected survival less than 6 months at randomization
- Other conditions deemed unsuitable by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong 519000 Recruiting
Zhuhai, China
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here