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

RecruitingPhase 2Ages 18 Years - 75 YearsAllThe First Affiliated Hospital of Xiamen University
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In plain words

What the trial is, and whether it could suit you

This study is a single-arm, open-label, prospective, and exploratory investigation aimed at examining the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค Upper Limit of Normal (ULN); AST and ALT โ‰ค 2.5 ร— ULN; Alkaline phosphatase โ‰ค 5 ร— ULN; 1.7. Renal function: Creatinine clearance โ‰ฅ 80 mL/min; 1.8. Hematological tests: Absolute neutrophil count (ANC) โ‰ฅ 2 ร— 109/L, platelet count โ‰ฅ 100 ร— 109/L, and hemoglobin โ‰ฅ 9 g/dL; 1.9. No severe dysfunction of heart, lung, and other vital organs; 1.10. Performance Status (PS) score โ‰ค 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.
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What it tests

  • SBRT combined with Nimotuzumab followed by Tislelizumab
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Where

2 sites
The First Affiliated Hospital of Xiamen University
Xiamen, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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