Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma
NCT ID: NCT07303283
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2026-03-01
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant Becotatug Vedotin
Adjuvant therapy with Becotatug Vedotin
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.
Observation
Only Clinical follow-up and surveillance
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Original clinical staged as TanyN2-3M0 or T4N1M0 (according to AJCC 9th edition), with no evidence of distant metastasis.
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Wuzhou Red Cross Hospital
OTHER
First People's Hospital of Yulin
OTHER
Guigang People's Hospital
OTHER
Hainan Cancer Hospital
OTHER
Affiliated Hospital of North Sichuan Medical College
OTHER
Affiliated Hospital of Youjiang Medical University for Nationalitie
UNKNOWN
Lingshan people's Hospital
UNKNOWN
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
LiuZhou People's Hospital
OTHER
The Third people's hospital of Hechi
UNKNOWN
Kai Hu
OTHER
Responsible Party
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Kai Hu
professor
Locations
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Central Contacts
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Other Identifiers
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GuangxiMUHK5
Identifier Type: -
Identifier Source: org_study_id