OncoMatch/Clinical Trials/NCT05342792
Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma
Is NCT05342792 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PD-1 antibody and Capecitabine for nasopharyngeal carcinoma.
Treatment: PD-1 antibody · Capecitabine — This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T4N+M0, TANYN2-3M0, TANYNANYM0 PRETREATMENT EBVDNA ≥ 4000 COPIES/ML (AJCC/UICC 8th edition)
Locoregionally advanced nasopharyngeal carcinoma (T4N + or TanyN2-3M0, or TanyNanyM0 pretreatment EBVDNA ≥ 4000 copies/mL) was diagnosed according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 8th edition clinical staging system.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: induction and concurrent chemoradiotherapy — standard
Induction and concurrent chemoradiotherapy with the recommended regimen have been completed
Cannot have received: surgical treatment, biological therapy, or immunotherapy during or before radiotherapy
Patients who received surgical treatment, biological therapy, or immunotherapy during or before radiotherapy
Cannot have received: chemotherapy or surgery (except diagnostic) of the primary tumor or lymph nodes before standard treatment
Chemotherapy or surgery (except diagnostic) of the primary tumor or lymph nodes before standard treatment
Cannot have received: radiation therapy prior to standard therapy (except for non-melanoma skin cancer)
History of radiation therapy prior to standard therapy (except for non-melanoma skin cancer)
Cannot have received: other chemotherapy, biological therapy, or immunotherapy
Patients who are receiving or are likely to receive other chemotherapy, biological therapy, or immunotherapy
Lab requirements
Blood counts
white blood cell count > 4 × 10^9/L, hemoglobin > 90 g/L, platelet count > 100 × 10^9/L
Kidney function
creatinine clearance ≥ 60 mL/min
Liver function
total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN; alkaline phosphatase ≤ 2.5x ULN
Normal bone marrow function: white blood cell count > 4 × 10^9/L, hemoglobin concentration > 90 g/L, platelet count > 100 × 10^9/L; Normal liver and kidney function: total bilirubin ≤ 1.5 times the upper limit of normal; aspartate aminotransferase and/or alanine aminotransferase ≤ 2.5 times the upper limit of normal; alkaline phosphatase ≤ 2.5 times the upper limit of normal; creatinine clearance ≥ 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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