Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasophar… (NCT07248696) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasopharyngeal Carcinoma: A Prospective, Phase II Trial
China32 participantsStarted 2025-10-04
Plain-language summary
This study is aimed to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and response-adapted radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years.
✓. Newly diagnosed nasopharyngeal carcinoma with pathological confirmation of non-keratinizing carcinoma (WHO type II or III).
✓. Stage IV (T1-4N0-3M1a and M1b) according to the AJCC/UICC 9th edition clinical staging system for NPC.
✓. Achieved complete response (CR) or partial response (PR) by imaging evaluation after 4-6 cycles of GP chemotherapy combined with tislelizumab.
✓. ECOG performance status: 0-1.
✓. Adequate organ function.
Exclusion criteria
✕. Recurrent or metastatic nasopharyngeal carcinoma after radical treatment.
✕. Other malignancies diagnosed or treated within the past 5 years (except basal cell carcinoma, cervical carcinoma in situ, and superficial bladder tumors).
✕. Previous treatment with immune checkpoint inhibitors.
✕. Pregnancy or lactation (consider pregnancy testing for women of childbearing age and emphasize effective contraception during treatment).
✕. Active or history of autoimmune diseases.
✕. Concurrent medical condition requiring the use of immunosuppressive medications.