Becotatug vedotin added to radiation and adjuvant therapy for locally advanced nasopharyngeal cancer with a poor response to induction chemo‑immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑arm Phase II study enrolling patients with high‑risk locally advanced non‑keratinizing nasopharyngeal carcinoma who show a suboptimal response after three cycles of induction chemo‑immunotherapy. Suboptimal response is defined by detectable plasma EBV DNA (>0 copies/mL) or imaging showing stable or progressive disease. Participants will receive becotatug vedotin added during the concurrent radiotherapy phase and the adjuvant phase to test whether this different mechanism of action improves outcomes. The goal is to collect evidence-based data on safety and efficacy to determine whether this regimen can be an additional option for these higher‑risk patients.

Why it matters

Who can join: the full rules

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 Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
* Efficacy after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) 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 carcinoma (WHO Type I).
* Patients who have previously received radiotherapy or systemic chemotherapy.
* Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
* HIV positive.
* History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
* Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Pei-Yu Huang
• Email: huangpy@sysucc.org.cn
• Phone: +86-20-87343379

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.