Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

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)

Interventions

DRUG

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.

DRUG

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.

DRUG

Cisplatin

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

RADIATION

intensity-modulated radiotherapy

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

DRUG

Gemcitabine (GEM)

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

DRUG

Cisplatin

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Hunan Provincial Cancer Hospital

  collaborator UNKNOWN

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Wuzhou Red Cross Hospital

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-05

Primary Completion

2030-04-01

Completion

2032-04-01

Countries

• China

Study Locations