PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC

Recruiting now · Phase 2

Conditions studied: Nasopharangeal Cancer, Recurrent Nasopharynx Carcinoma

In brief

This phase II randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus selective re-irradiation in locally advanced recurrent nasopharyngeal carcinoma. The study aims to determine whether sequential radiotherapy provides additional survival benefit beyond systemic immunochemotherapy.

Key facts

Study ID

NCT07332247

Run by

Sun Yat-sen University

People needed

94

Starts

2026-02-03

Expected to finish

2035-02-03

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-70 years, any gender.
• Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.
• Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).
• Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.
• ECOG performance status 0-1.
• Expected survival ≥ 3 months.
• No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma
• No contraindications to immunotherapy, chemotherapy, or re-irradiation.
• 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
• 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.

You may not qualify if…

• Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence
• Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.
• Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
• History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.
• 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.
• 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.
• Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies/mL
• Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative
• HIV infection
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia).
• Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis.
• Major surgery within 4 weeks before enrollment, or unhealed surgical wound.
• Pregnant or breastfeeding women, or those planning pregnancy during the study period.
• Known allergy or hypersensitivity to study drugs or their excipients.
• Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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