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Clinical Trial NCT07459296 for Nasopharyngeal Carcinoma (NPC) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC Phase 3 266 Randomized Overall Survival

Recruiting
Clinical Trial NCT07459296 is designed to study Treatment for Nasopharyngeal Carcinoma (NPC). It is a Phase 3 interventional study that is recruiting, having started on March 5, 2026, with plans to enroll 266 participants. Led by First Affiliated Hospital of Guangxi Medical University, it is expected to complete by April 1, 2032. The latest data from ClinicalTrials.gov was last updated on March 16, 2026.
Brief Summary
This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy 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)...Show More
Detailed Description
This is a multicenter, randomized, controlled phase III clinical study targeting patients with high-risk locally advanced nasopharyngeal carcinoma (stage T1-4N2-3M0 or T4N1M0 per the 9th AJCC/UICC staging system), with a planned enrollment of 266 patients who will be randomized 1:1 into an experimental group and a control group under an open-label, stratified randomization design. The primary endpoint of the study is...Show More
Official Title

Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial

Conditions
Nasopharyngeal Carcinoma (NPC)
Other Study IDs
  • 2026-K0013
NCT ID Number
NCT07459296
Start Date (Actual)
2026-03-05
Last Update Posted
2026-03-16
Completion Date (Estimated)
2032-04-01
Enrollment (Estimated)
266
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
Nasopharyngeal Carcinoma
Becotatug Vedotin
Sintilimab
Concurrent Chemoradiotherapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBecotatug Vedotin followed by CCRT plus Sintilimab
Patients will receive Becotatug Vedotin induction therapy followed by CCRT combined with neoadjuvant and adjuvant sintilimab
Becotatug Vedotin
Becotatug vedotin 2.3 mg/kg will be given on Day 1 of induction therapy, once every 3 weeks for a total of 3 cycles.
Sintilimab
In the induction treatment phase, sintilimab 200 mg will be administered on Day 1 of each induction cycle, once every 3 weeks, for a total of 3 cycles. In the adjuvant treatment phase, sintilimab 200 mg will be given on Day 1, initiated 3 weeks after the completion of radiotherapy, once every 3 weeks, for a total of 9 cycles.
Cisplatin
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
intensity-modulated radiotherapy
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions
Active ComparatorInduction Chemotherapy followed by CCRT
Patients will receive gemcitabine plus cisplatin induction chemotherapy followed by CCRT
Cisplatin
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
intensity-modulated radiotherapy
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions
Gemcitabine (GEM)
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Cisplatin
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Event-free survival (EFS)
The time interval from randomization to the first treatment failure or the last follow-up if there is no treatment failure. Treatment failure is defined as local/cervical residual disease 16 weeks after radiotherapy, local/cervical recurrence, distant metastasis, or death due to any cause,whichever occurred first.
3 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival (OS)
The time interval from randomization to the date of death from any cause.
3 years
Distant metastasis-free survival (DMFS)
The time interval from randomization to the date of first distant metastasis, or death from any cause, whichever occurred first.
3 years
Locoregional recurrence-free survival (LRFS)
The time interval randomization to the date of locoregional persistence, 1st locoregional recurrence, or death from any cause, whichever occurred first.
3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
3 years
Quality of life (QoL)
The change of QoL from randomization to the start of radiotherapy,the 16th fraction of radiotherapy, the end of radiotherapy, 43 weeks (at the end of sintilimab treatment in the sintilimab arm and the corresponding timepoint in the chemoradiation arm). The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
3 years
Event-free survival (EFS) within different subgroups
analyses for EFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (\<4000copies/ml vs. ≥4000copies/ml), EGFR expression status (positive vs negative), different PD-L1 expression levels (\<1% vs. ≥1%), tertiary lymphoid structure (+ vs. -), age, gender, performance status, T category, N category, and stage (II vs. III).
3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Voluntarily participate in the study and sign the informed consent form in writing.
  2. Aged 18-70 years, male or non-pregnant female.
  3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
  4. Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.
  5. ECOG performance status score of 0-1.
  6. Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L.
  7. 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.
  8. Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula).
  9. Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.

  1. Aged > 70 years or < 18 years.
  2. Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
  3. Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).
  4. Patients who have previously received radiotherapy or systemic chemotherapy.
  5. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA > 1000 copies/mL or 200 IU/mL.
  6. Positive for hepatitis C virus antibody (anti-HCV).
  7. 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).
  8. Patients who received systemic glucocorticoids (equivalent to prednisone > 10 mg/day) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg/day, inhaled or topical glucocorticoids are eligible for enrollment.
  9. Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix).
  10. Patients with a history of interstitial lung disease.
  11. Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future.
  12. Pregnant or lactating females.
  13. Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.
  14. Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.
  15. Patients with known history of HIV infection.
  16. Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family/social factors.
First Affiliated Hospital of Guangxi Medical University logoFirst Affiliated Hospital of Guangxi Medical University
Study Central Contact
Contact: Min Kang, MD, +86-771-5356509, [email protected]
1 Study Locations in 1 Countries

Guangxi

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Min Kang, MD, Contact, +86-771-5356509, [email protected]
Recruiting