Focused radiation plus nimotuzumab followed by tislelizumab for oligoprogressive recurrent or metastatic nasopharyngeal cancer after prior immunotherapy

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

This is a single-arm, open-label, prospective Phase 2 trial testing a combined local and systemic approach in patients with oligoprogressive recurrent or metastatic non-keratinizing nasopharyngeal carcinoma after prior anti–PD‑1 therapy. Eligible patients will receive stereotactic body radiotherapy (SBRT) to progressing lesions together with nimotuzumab, followed by systemic tislelizumab; the primary short-term endpoint is objective response rate (ORR). The trial focuses on patients with 1–5 progressing metastatic lesions after immunotherapy failure and includes standard safety and laboratory eligibility requirements. The design is exploratory and intended to generate preliminary efficacy and safety data to inform further research.

Why it matters

Who can join: the full rules

1. Inclusion Criteria:

   1.1. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 1.2. Patients with recurrent/metastatic nasopharyngeal carcinoma who have previously received first-line treatment including anti-PD-1 immune checkpoint inhibitor therapy and failed, presenting with oligoprogression (1-5 metastatic lesions); 1.3. Eligible to receive SBRT, Tislelizumab, and Nimotuzumab; 1.4. No history of other malignant tumors; 1.5. Male or female, aged 18-75 years; 1.6. Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5 × ULN; 1.7. Renal function: Creatinine clearance ≥ 80 mL/min; 1.8. Hematological tests: Absolute neutrophil count (ANC) ≥ 2 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL; 1.9. No severe dysfunction of heart, lung, and other vital organs; 1.10. Performance Status (PS) score ≤ 2.
2. Exclusion Criteria:

2.1. Disagree to sign the informed consent form; 2.2. Patients who cannot comply with regular follow-ups due to psychological, social, family, or geographical reasons; 2.3. Receiving other experimental treatments as part of a clinical study (during the treatment period of the clinical study); 2.4. Severe, uncontrolled infections or medical conditions; 2.5. Major organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy or immunotherapy; 2.6. Factors affecting drug administration, distribution, metabolism, or excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 2.7. Overexposure to glucocorticoids within 2 weeks before immunotherapy; 2.8. Long-term use of immunosuppressive agents after organ transplantation.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Enrolling by invitation

Study contacts

• Study coordinator: San-Gang Wu, MD., PHD
• Email: wusg@xmu.edu.cn
• Phone: 865922139531

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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.