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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 (May 2026). This Phase 2 trial studies Anti-PD1 antibody, nimotuzumab and capecitabine for nasopharyngeal carcinoma.

Phase 2RecruitingJiangxi Provincial Cancer HospitalNCT06259721Data as of May 2026

Treatment: Anti-PD1 antibody, nimotuzumab and capecitabineThe 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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

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.

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