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

A Prospective, Single-Arm, Exploratory Study of SBRT Combined With Nimotuzumab and Sequential Tislelizumab for Oligoprogressive Distant Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line Immunotherapy

This trial will try focused stereotactic radiation together with the antibody nimotuzumab, followed by the PD‑1 drug tislelizumab, in people whose recurrent or metastatic nasopharyngeal cancer has progressed at 1–5 spots after prior anti–PD‑1 treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Drugs / interventions: Tislelizumab, Nimotuzumab, immunotherapy
• Locations: 2 sites (Xiamen, Fujian and 1 other locations)
• Trial ID: NCT06676722 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (18–75) with pathologically confirmed non-keratinizing recurrent or metastatic nasopharyngeal carcinoma who previously received anti‑PD‑1 therapy and now have oligoprogression of 1–5 metastatic lesions and adequate organ function.

Not a fit: Patients with widespread progression beyond 5 lesions, other active malignancies, severe organ dysfunction, or who cannot tolerate SBRT or antibody therapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could shrink progressing lesions and restore disease control in patients whose cancer progressed after prior PD‑1 therapy.

How similar studies have performed: Some prior studies combining SBRT with immunotherapy or combining EGFR antibodies with radiotherapy in head and neck cancers have shown promising signals, but using SBRT plus nimotuzumab followed by PD‑1 re‑challenge in oligoprogressive NPC is largely novel and unproven.

Eligibility criteria

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 this trial is running

Xiamen, Fujian and 1 other locations

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Enrolling_by_invitation)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: San-Gang Wu, MD., PHD

Conditions Nasopharyngeal Cancinoma; SBRT; Immunotherapy