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NOT YET RECRUITING
NCT07555860
PHASE2

Becotatug Vedotin Plus PD-1 Monoclonal Antibody and Radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This exploratory clinical study will enroll patients with unresectable locally recurrent nasopharyngeal carcinoma to receive two cycles of becotatug vedotin plus a PD-1 monoclonal antibody, followed by sequential radiotherapy and PD-1 monoclonal antibody maintenance until disease progression or unacceptable toxicity. The study aims to evaluate the efficacy and safety of this treatment strategy.

Official title: An Open-Label, Single-Arm, Single-Center Phase II Study of Induction Becotatug Vedotin Plus a PD-1 Inhibitor Followed by Radiotherapy With PD-1 Maintenance in Patients With Unresectable Locally Recurrent Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-04-20

Completion Date

2029-12-31

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin

Becotatug vedotin will be administered at 2.0 mg/kg intravenously on Day 1 every 3 weeks for 2 cycles as induction therapy, in combination with a PD-1 monoclonal antibody.

DRUG

Toripalimab

Toripalimab will be administered at 240 mg intravenously on Day 1 every 3 weeks. Toripalimab is one of the optional PD-1 monoclonal antibodies in this study and will be used as an alternative to camrelizumab, not in combination with camrelizumab. It will be given during induction therapy, concurrently with radiotherapy, and as maintenance therapy after radiotherapy until disease progression or unacceptable toxicity.

DRUG

Camrelizumab

Camrelizumab will be administered at 200 mg intravenously on Day 1 every 3 weeks. Camrelizumab is one of the optional PD-1 monoclonal antibodies in this study and will be used as an alternative to toripalimab, not in combination with toripalimab. It will be given during induction therapy, concurrently with radiotherapy, and as maintenance therapy after radiotherapy until disease progression or unacceptable toxicity.

DRUG

Intensity-Modulated Radiotherapy

Intensity-modulated radiotherapy will be delivered once daily, 5 days per week. Prescribed doses are 60 Gy in 27 fractions to PTVnx, 60-64 Gy in 27 fractions to PTVnd, and 54 Gy in 27 fractions to PTV1.