OncoMatch/Clinical Trials/NCT06259721
Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
Is NCT06259721 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Anti-PD1 antibody, nimotuzumab and capecitabine for nasopharyngeal carcinoma.
Treatment: Anti-PD1 antibody, nimotuzumab and capecitabine — The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy — first-line for recurrent or metastatic disease
Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation.
Cannot have received: anti-EGFR monoclonal antibody (nimotuzumab, cetuximab)
Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab, cetuximab)
Cannot have received: anti-PD-1 monoclonal antibody
Patients who have previously received ... anti-PD-1 monoclonal antibodies
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin ≥9 g/dL
Kidney function
Creatinine ≤1.5x ULN or creatinine clearance rate ≥50 ml/min (Cockcroft-Gault formula)
Liver function
serum total bilirubin (TBIL) ≤1.5x ULN; ALT and AST ≤2.5x ULN (≤5x ULN with liver metastases)
Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥ 75×10^9/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06259721 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-EGFR monoclonal antibody, anti-PD-1 monoclonal antibody disqualifies patients from enrollment.
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.
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