Phase 3: testing Becotatug Vedotin for Nasopharyngeal Carcinoma (NPC)
This study is a multicenter, randomly assigned, controlled phase III clinical trial aiming to investigate the how well it works and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), side effects, and quality of life.
Official registry: https://clinicaltrials.gov/study/NCT07459296 · First Affiliated Hospital of Guangxi Medical University · enrollment listed as 266
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Becotatug Vedotin, Sintilimab, or Cisplatin. The registry lists allocation as randomized. This study is a multicenter, randomly assigned, controlled phase III clinical trial aiming to investigate the how well it works and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC).
They plan to enroll about 266 people at Nanning. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial
Interventions: Becotatug Vedotin, Sintilimab, Cisplatin, intensity-modulated radiotherapy, Gemcitabine (GEM), Cisplatin
Primary outcome (registry wording): Event-free survival (EFS)
Who it is for (from inclusion criteria)
- Ages 18 Years to 70 Years
- Aged 18-70 years, male or non-pregnant female
- Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III)
- Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis
- how well you can do daily activities (ECOG score) score of 0-1
- Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L
- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN
- Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula)
Who the registry excludes
- Aged \> 70 years or \< 18 years
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma
- Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I)
- Patients who have previously received radiotherapy or systemic chemotherapy
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \> 1000 copies/mL or 200 IU/mL
- Positive for hepatitis C virus antibody (anti-HCV)
- Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia)
Public study contact (from the registry)
Min Kang, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (recruiting)
FAQ about this NCT record
Is NCT07459296 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07459296?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07459296?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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