PD-1 immunotherapy with chemotherapy followed by immediate or delayed local radiation for newly metastatic nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with newly diagnosed (de novo) metastatic nasopharyngeal carcinoma receive first‑line PD‑1 inhibitor combined with gemcitabine and cisplatin (GP). Those who achieve a complete or partial response after 4–6 cycles are randomized in this phase III trial to immediate locoregional radiotherapy or to delayed (salvage) radiotherapy only if needed. The primary design is a non‑inferiority comparison focused on survival outcomes while monitoring treatment‑related toxicity. The trial is being conducted at major cancer centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, China Recruiting
• Guangxi Medical University Cancer Hospital
  Nanning, China Recruiting
• Hunan Cancer Hospital
  Changsha, China Not yet recruiting
• Fujian Cancer Hospital
  Fuzhou, China Not yet recruiting

Study contacts

• Study coordinator: Haiqiang Mai, PhD, MD
• Email: maihq@sysucc.org.cn
• Phone: +86-020-87343643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.