Becotatug Vedotin Plus PD-1 Monoclonal Antibody and Radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
NCT07555860 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-04-29
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.
Conditions
- Nasopharyngeal Carcinoma
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.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Yi-Jun Hua, MD · Sun Yat-sun University Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-20
- Primary Completion
- 2027-12-31
- Completion
- 2029-12-31
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