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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

Nimotuzumab

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06509009 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require EGFR?

Yes, EGFR expression positive is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 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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