NCT07235319 PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy in De Novo Metastatic NPC
| NCT ID | NCT07235319 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharangeal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2026-04-16 |
| Primary Completion | 2032-04-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 260 participants in total. It began in 2026-04-16 with a primary completion date of 2032-04-16.
⚠ 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 phase III randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus salvage locoregional radiotherapy in de novo metastatic nasopharyngeal carcinoma. The study aims to evaluate whether salvage locoregional radiotherapy is non-inferior to immediate radiotherapy following PD-1 inhibitor plus GP in de novo metastatic NPC, with potential for reduced toxicity.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-70 years, any gender. 2. Histologically confirmed differentiated non-keratinizing carcinoma or undifferentiated non-keratinizing carcinoma by tissue biopsy, with radiologically detectable metastatic lesions. Pathological confirmation of metastatic lesions is recommended but not mandatory. 3. ECOG performance status 0-1. 4. Stage IV NPC according to the 9th edition of the UICC/AJCC staging system. 5. No prior anti-tumor treatment for NPC (radiotherapy, chemotherapy, surgery, etc.). 6. Expected survival ≥ 3 months. 7. At least one measurable lesion per RECIST v1.1. 8. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy. 9. Adequate organ function within 14 days before first dose, defined as: Hematology：Hemoglobin ≥ 90 g/L，ANC ≥ 1.5 × 10⁹/L，Platelet count ≥ 100 × 10⁹/L Renal Function：Creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) / eGFR ≥ 60 mL/min Liver Function：Total bilirubin ≤ 1.5 × ULN，AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN in the presence of liver metastases 10. INR or PT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range，aPTT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range Exclusion Criteria: 1. Prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy. 2. Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors. 3. Presence of uncontrolled or symptomatic central nervous system (CNS) metastases. 4. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer. 5. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma/atopy. 6. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms. 7. Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies/mL 8. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative 9. HIV infection 10. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia). 11. Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis. 12. Major surgery within 4 weeks before enrollment, or unhealed surgical wound. 13. Pregnant or breastfeeding women, or those planning pregnancy during the study period. 14. Known allergy or hypersensitivity to study drugs or their excipients. 15. Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07235319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharangeal Cancer. 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 NCT07235319 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 260 participants.
Is NCT07235319 currently recruiting?
Yes, NCT07235319 is actively recruiting participants. Contact the research team at maihq@sysucc.org.cn for enrollment information.
Where is the NCT07235319 trial being conducted?
This trial is being conducted at Guangzhou, China, Changsha, China, Fuzhou, China, Hangzhou, China and 1 additional location.
Who is sponsoring the NCT07235319 clinical trial?
NCT07235319 is sponsored by Sun Yat-sen University. The trial plans to enroll 260 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.