SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with a type of throat cancer called nasopharyngeal carcinoma (NPC) that has come back or spread to other parts of the body after previous immunotherapy has stopped working. The study combines a precise form of radiation therapy called SBRT with two medicines, Nimotuzumab and Tislelizumab, to see if this combination can help shrink tumors or stop them from growing in patients who have a small number (1 to 5) of new cancer spots.

People who might be eligible for this trial are adults aged 18 to 75 with confirmed NPC that has returned or spread after initial immunotherapy, and who are healthy enough to receive this treatment. Participants can expect to receive targeted radiation to their cancer areas along with these medicines and will be closely monitored to see how well the treatment works and if there are any side effects. The study is currently recruiting patients and focuses on those whose cancer shows limited progression, aiming to find better options when standard treatments have not been successful.

Gender

ALL

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.