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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05290194 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages