A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradioth… (NCT07392320) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
China142 participantsStarted 2026-02-10
Plain-language summary
In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Voluntary participation and written informed consent must be signed.
* Age between 18 and 70 years, male or non-pregnant female.
* Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
* Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml.
* Efficacy after 3 cycles of induction immunochemotherapy assessed as complete response (CR) or partial response (PR) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
* ECOG performance status score of 0 or 1.
* Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010\^9/L, and Platele (PLT) ≥10010\^9/L.
* Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
* Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
Exclusion Criteria:
* Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
* Pathological diagnosis of keratinizing squamous cell carc…