RecruitingPhase 3NCT07459296

Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

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


Sponsor

First Affiliated Hospital of Guangxi Medical University

Enrollment

266 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of becotatug vedotin (an antibody-drug conjugate that delivers chemotherapy directly to cancer cells) plus sintilimab (an immunotherapy that helps the immune system attack cancer) together with standard chemotherapy and radiation for patients with locally advanced nasopharyngeal carcinoma (a type of throat cancer at the back of the nasal passage). **You may be eligible if...** - You are between 18 and 70 years old - You have been confirmed to have a specific type of nasopharyngeal carcinoma (WHO type II or III) - Your cancer is locally advanced (involving nearby lymph nodes) without distant spread - You have not received any prior radiotherapy or chemotherapy for this cancer - Your blood counts, liver, and kidney function meet minimum requirements **You may NOT be eligible if...** - Your cancer has recurred or spread to distant organs - Your cancer is the keratinizing type (WHO type I) - You have active hepatitis B (with high viral load), active hepatitis C, or HIV - You have an active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBecotatug 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.

DRUGSintilimab

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.

DRUGCisplatin

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

RADIATIONintensity-modulated radiotherapy

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

DRUGGemcitabine (GEM)

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

DRUGCisplatin

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation


Locations(1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07459296


Related Trials