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OncoMatch/Clinical Trials/NCT06509009

Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Is NCT06509009 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nimotuzumab for nasopharyngeal carcinoma by ajcc v8 stage.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06509009Data as of May 2026

Treatment: NimotuzumabThe goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabine/cisplatin regimen treatment recurrent/distant-metastasis nasopharyngeal carcinoma.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: EGFR expression positive

EGFR expression positive

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiotherapy

Subjects who have received radiotherapy ... within the past six months

Cannot have received: chemotherapy

Subjects who have received ... chemotherapy ... within the past six months

Cannot have received: immunosuppressive agents

Subjects who have received ... immunosuppressive agents ... within the past six months

Cannot have received: monoclonal antibodies

Subjects who have received ... monoclonal antibodies ... within the past six months

Cannot have received: EGFR tyrosine kinase inhibitor

Subjects who have received ... oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) ... within the past six months

Cannot have received: anti-angiogenic drugs

Subjects who have received ... anti-angiogenic drugs within the past six months

Lab requirements

Blood counts

white blood cell count ≥ 3 × 10^9/l; absolute neutrophil count ≥ 1.5 × 10^9/l; platelet count ≥ 100 × 10^9/l; hemoglobin level ≥ 90 g/l

Kidney function

serum creatinine level ≤ 1.2 mmol/l or creatinine clearance ≥ 60 ml/min

Liver function

serum total bilirubin ≤ 1.5 × uln (in case of liver metastasis, ≤ 3.0 × uln); ast and alt ≤ 2.5 × uln (in case of liver metastasis, ≤ 5.0 × uln)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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