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Not yet recruiting NCT07303283

Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma

Phase II Interventional Nasopharyngeal Carcinoma (NPC) Locoregionally Advanced Nasopharyngeal Carcinoma Adjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Becotatug Vedotin.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma (NPC), Locoregionally Advanced Nasopharyngeal Carcinoma, Adjuvant Therapy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Single-agent Becotatug Vedotin as Adjuvant Therapy for High-risk Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial

Overview

This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).

Detailed description

Eligible patients with high-risk locoregionally advanced NPC, defined as T4N1M0 disease, any T with N2-3M0 disease, stable disease (SD) or progressive disease (PD) after induction chemotherapy, or detectable plasma EBV DNA following induction chemotherapy, who have completed curative-intent chemoradiotherapy, will be randomly assigned to either the adjuvant Becotatug Vedotin group or the observation group. Participants assigned to the experimental group will receive Becotatug Vedotin at a dose of 2.3 mg/kg administered intravenously on Day 1 of each 21-day cycle for a total of three cycles. Participants assigned to the control group will undergo observation alone.

The primary endpoint is event-free survival (EFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), locoregional failure-free survival (LRFFS), and safety. All efficacy analyses will be performed in the intention-to-treat (ITT) population. Safety analyses will be conducted in the safety population, defined as all randomized patients.

Interventions

  • Drug Becotatug Vedotin
    This group will receive Becotatug Vedotin at a dose of 2.3 mg/kg on day 1 of each 3-week cycle for a total of 3 cycles.

Primary outcome measures

  • event-free survival [Time frame: 2 years]
Secondary outcome measures (4)
  • overall survival [Time frame: 2 years]
  • distant metastasis-free survival [Time frame: 2 years]
  • Locoregional failure-free survival [Time frame: 2 years]
  • Treatment-Related Adverse Events [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
  • Eligible patients with high-risk locoregionally advanced NPC, defined as AJCC (9th edition) stage T4N1M0 or Tany N2-3M0 disease, or persistent high-risk features after induction chemotherapy (SD, PD, or detectable plasma EBV DNA).
  • ECOG performance status ≤1.
  • Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.
  • No later than 6 weeks after the completion of the last radiotherapy treatment.
  • Adequate hematologic (neutrophil count > 1.5×10\^9/L, hemoglobin > 90g/L and platelet count > 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase < 2.5×ULN) and renal function (creatinine clearance > 50 ml/min)
  • Patients must be informed of the investigational nature of this study and give written informed consent.
  • Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

Exclusion criteria

  • Patients who could not tolerate or were allergic to Becotatug Vedotin.
  • Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal, or antiviral therapy before randomization, including but not limited to tuberculosis infection.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  • Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.
  • Patients who are known to be intolerant or sensitive to any therapeutic agents.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Guangxi Medical University — Nanning

Identifiers

NCT: NCT07303283 · GuangxiMUHK5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗