Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07496190

Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy

Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA >0 copies/mL or imaging response evaluation showing SD/PD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival. Based on the above research and background, the investigators plan to conduct the first prospective, single-arm, phase II clinical study of becotatug vedotin in patients with locally advanced nasopharyngeal carcinoma who are suboptimal responsive to immuno-induction chemotherapy, aiming to obtain sufficient evidence-based medical data to provide an additional treatment option for the concurrent and adjuvant phases of nasopharyngeal carcinoma.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nasopharyngeal Cancinoma (NPC)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Pei-Yu Huang

CONTACT

[email protected]

+86-20-87343379

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Becotatug Vedotin

Drug

Becotatug vedotin during concurrent radiotherapy and the adjuvant phase

Primary outcomes

  1. Progression-free survival

    Time frame: 3 years

    Progression-free survival is calculated from the date of treatment initiation to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

    Overall survival is calculated from the date of treatment initiation to death from any cause.

  2. Locoregional recurrence-free survival

    Time frame: 3 years

    Locoregional recurrence-free survival is calculated from the date of treatment initiation to the date of documented locoregional recurrence or death from any cause.

  3. Distant metastasis-free survival

    Time frame: 3 years

    Distant metastasis-free survival is calculated from the date of treatment initiation to the date of documented distant metastasis or death from any cause.

  4. Incidence of acute toxicity as assessed by CTCAE v5.0

    Time frame: 3 years

    Acute adverse events (those that occurred within 1 year of randomisation) are graded according to the Common Terminology Criteria for Adverse Events (version 5.0).

  5. Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group

    Time frame: 3 years

    Late adverse events (those occurring >1 year after randomisation) are graded according to the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group.

Study contacts

Contact information is provided by the study sponsor or research team.

Pei-Yu Huang

CONTACT

[email protected]

+86-20-87343379

Qi Yang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Becotatug Vedotin for Locoregionally Advanced Nasopharyngeal Carcinoma With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy: A Prospective, Single-Arm, Phase II Trial

Important dates

Study start
2026
Primary completion
2032
Study completion
2034
First posted
Mar 27, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.