Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (RearTurbo)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Adjuvant Therapy; Nasopharyngeal Carcinoma (NPC); Locoregionally Advanced Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Becotatug Vedotin

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: kai hu; Phone Number: +867715359801; Email: hukai@gxmu.edu.cn

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
2. 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).
3. ECOG performance status ≤1.
4. Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.
5. No later than 6 weeks after the completion of the last radiotherapy treatment.
6. 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)
7. Patients must be informed of the investigational nature of this study and give written informed consent.
8. 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:

1. Patients who could not tolerate or were allergic to Becotatug Vedotin.
2. 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.
3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
5. Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.
6. Patients who are known to be intolerant or sensitive to any therapeutic agents.
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjuvant Becotatug Vedotin; Adjuvant therapy with Becotatug Vedotin	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.
No Intervention: observation; Clinical follow-up and surveillance only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
event-free survival	calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	calculated from the date of randomisation to death	2 years
Locoregional failure-free survival	calculated from the date of randomisation to the first locoregional failure	2 years
distant metastasis-free survival	calculated from the date of randomisation to the first distant metastasis	2 years
Treatment-Related Adverse Events	graded according to NCI CTCAE v5.0	2 years

Collaborators and Investigators

• Sponsor: Kai Hu
• Collaborators: Wuzhou Red Cross Hospital; Fujian Cancer Hospital; Hunan Cancer Hospital; Guangxi Nanxishan Hospital; Lingshan people's Hospital; LiuZhou People's Hospital; First People's Hospital of Yulin; Guigang People's Hospital; Affiliated Hospital of North Sichuan Medical College; Hainan Cancer Hospital; Liuzhou Workers' Hospital; Affiliated Hospital of Youjiang Medical University for Nationalitie; The Third people's hospital of Hechi; the second People's Hospital of qinzhou

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2033

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Nasopharyngeal Carcinoma; Adjuvant therapy; Becotatug Vedotin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine
• Other Study ID Numbers: GuangxiMUHK5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No