OncoMatch/Clinical Trials/NCT05290194
Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma
Is NCT05290194 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-1 inhibitor and Capecitabine for radiotherapy.
Treatment: PD-1 inhibitor · Capecitabine — This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV (AJCC eighth edition)
Metastatic disease required
newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen (gemcitabine, cisplatin, PD-1 monoclonal antibody) — first-line
after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease
Cannot have received: induction chemotherapy
Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments
Cannot have received: adjuvant chemotherapy
Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments
Cannot have received: concurrent chemoradiotherapy
Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments
Cannot have received: surgery
Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments
Lab requirements
Blood counts
Neutrophil ANC ≥ 2.0 × 10^9/L; platelet count PLT ≥ 100 × 10^9/L; hemoglobin HB ≥ 90 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL/min
Liver function
ALT, AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN
Cardiac function
Uncontrolled cardiac clinical symptoms or diseases, such as: heart failure of NYHA Grade II or higher; unstable angina pectoris; myocardial infarction within 1 year; supraventricular or arrhythmia requiring clinical intervention [excluded]
Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor): Neutrophil ANC ≥ 2.0 × 10^9/L; platelet count PLT ≥ 100 × 10^9/L; hemoglobin HB ≥ 90 g/L; Serum albumin ≥ 28 g/L; ALT, AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL/min; INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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