NCT07328854 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma
| NCT ID | NCT07328854 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ming-Yuan Chen |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 346 participants in total. It began in 2025-11-20 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.
Eligibility Criteria
Inclusion Criteria: 1. Patients are informed of the basic content of this study and sign an informed consent form; 2. Age between 18 and 75 years; 3. Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III); 4. Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II); 5. KPS ≥ 70; 6. Normal bone marrow function: WBC ≥ 4 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L; 7. Imaging evaluation of treatment response after three cycles of GPP/TPP induction chemotherapy plus immunotherapy: CR or PR; 8. Plasma EBV DNA level decreases to 0 copies/mL or below the detection limit after induction chemotherapy; 9. Normal liver and kidney function: total bilirubin, AST, ALT ≤ 2.0 times the upper limit of normal, creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times the upper limit of normal. Exclusion Criteria: 1. Patients with recurrent/metastatic nasopharyngeal carcinoma; 2. Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment); 3. Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ; 4. Patients whose local/regional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance; 5. Patients with other severe medical conditions that may pose significant risks or impair trial compliance. Examples include unstable cardiac disease requiring treatment, renal disease, hepatic disease, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), severe psychiatric disorders, or other malignant tumours; 6. Patients with a history of severe hypersensitivity reactions to any component of PD-1 monoclonal antibodies; 7. History of allergic reactions to the chemotherapy drugs used in this study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin); 8. Patients with comorbidities requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects; 9. Patients with active tuberculosis, or those currently receiving antituberculosis treatment or who have received antituberculosis treatment within the past year prior to screening; 10. Other patients deemed ineligible for inclusion by the treating physician.
Contact & Investigator
Ming-Yuan Chen, MD,PhD
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT07328854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07328854 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 346 participants.
Is NCT07328854 currently recruiting?
Yes, NCT07328854 is actively recruiting participants. Contact the research team at chenmy@sysucc.org.cn for enrollment information.
Where is the NCT07328854 trial being conducted?
This trial is being conducted at Hefei, China, Fuzhou, China, Guangzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07328854 clinical trial?
NCT07328854 is sponsored by Ming-Yuan Chen. The principal investigator is Ming-Yuan Chen, MD,PhD at Sun Yat-sen University. The trial plans to enroll 346 participants.