Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

NCT07459296 | Recruiting Phase 3 DMC

• 1 other identifier: 2026-K0013
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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). 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), adverse events, and quality of life.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Nasopharyngeal Carcinoma; Becotatug Vedotin; Sintilimab; Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall survival (OS)

  3 years

• Distant metastasis-free survival (DMFS)

  3 years

• Locoregional recurrence-free survival (LRFS)

  3 years

• Adverse events (AEs) and serious adverse events (SAEs)

  3 years

• Quality of life (QoL)

  3 years

Study Arms (2)

Becotatug Vedotin followed by CCRT plus Sintilimab

EXPERIMENTAL

Patients will receive Becotatug Vedotin induction therapy followed by CCRT combined with neoadjuvant and adjuvant sintilimab

Drug: Becotatug Vedotin; Drug: Sintilimab; Drug: Cisplatin; Radiation: intensity-modulated radiotherapy

Induction Chemotherapy followed by CCRT

ACTIVE COMPARATOR

Patients will receive gemcitabine plus cisplatin induction chemotherapy followed by CCRT

Drug: Cisplatin; Radiation: intensity-modulated radiotherapy; Drug: Gemcitabine (GEM)

Interventions

Becotatug Vedotin DRUG

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.

Becotatug Vedotin followed by CCRT plus Sintilimab

Sintilimab DRUG

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.

Becotatug Vedotin followed by CCRT plus Sintilimab

Cisplatin DRUG

Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

Becotatug Vedotin followed by CCRT plus Sintilimab; Induction Chemotherapy followed by CCRT

intensity-modulated radiotherapy RADIATION

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions

Becotatug Vedotin followed by CCRT plus Sintilimab; Induction Chemotherapy followed by CCRT

Gemcitabine (GEM) DRUG

Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.

Induction Chemotherapy followed by CCRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in the study and sign the informed consent form in writing.
• 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.
• ECOG performance status 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).
• 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.

You may not qualify if:

• 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).
• 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.
• 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).
• Patients with a history of interstitial lung disease.
• 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.
• Pregnant or lactating females.
• 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.
• Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.
• Patients with known history of HIV infection.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead
• Xiangya Hospital of Central South University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Hunan Provincial Cancer Hospital: collaborator
• Affiliated Hospital of North Sichuan Medical College: collaborator
• First Hospital of China Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• First People's Hospital of Yulin: collaborator
• Wuzhou Red Cross Hospital: collaborator
• LiuZhou People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

sintilimab; Cisplatin; Radiotherapy, Intensity-Modulated; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Min Kang, MD

CONTACT

+86-771-5356509; kangmin@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2032
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)