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OncoMatch/Clinical Trials/NCT07000643

Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma

Is NCT07000643 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies non-drug interventions for nasopharyngeal carcinoma.

Phase 3RecruitingMan HuNCT07000643Data as of Jun 2026Location: China

This study is a prospective, open-label, multicenter, cohort, phase III non-inferiority clinical trial comparing proton therapy with photon radiotherapy for nasopharyngeal carcinoma. It intends to enroll histologically confirmed newly diagnosed nasopharyngeal carcinoma patients without distant metastasis (M0). Through a prospective 1:1 matched cohort study design, patients will be divided into the intensity-modulated proton therapy (IMPT) group and the intensity-modulated radiation therapy (IMRT) group. Systemic treatment regimens are formulated according to clinical guidelines.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage CT1-4N0-3M0 (AJCC 9th Edition)

Investigator-assessed nasopharyngeal carcinoma (cT1-4N0-3M0, AJCC 9th Edition); Presence of distant metastatic lesions (M1) [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

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

Cannot have received: systemic anti-tumor therapy

Lab requirements

Blood counts

ANC ≥1.5x10⁹/L; Platelets ≥75×10⁹/L; Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L

Kidney function

Serum creatinine ≤1.5×ULN AND creatinine clearance (Cockcroft-Gault) ≥60 ml/min

Liver function

AST and ALT ≤2.5×ULN

Cardiac function

Good coagulation function; simple laboratory abnormalities judged by the investigator to be without clinical significance; Myocardial enzyme spectrum: simple laboratory abnormalities judged by the investigator to be without clinical significance

Adequate organ function, subjects must meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥1.5x10⁹/L. Platelets ≥75×10⁹/L. Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN (Upper Limit of Normal) Serum creatinine ≤1.5×ULN AND creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml/min; Good coagulation function: simple laboratory abnormalities judged by the investigator to be without clinical significance; Myocardial enzyme spectrum: simple laboratory abnormalities judged by the investigator to be without clinical significance;

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

Frequently asked questions

Is NCT07000643 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.

What disease stage is eligible?

Stage CT1-4N0-3M0 is required.

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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