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| Name | Class |
|---|---|
| Wuzhou Red Cross Hospital | OTHER |
| First People's Hospital of Yulin | OTHER |
| Guigang People's Hospital | OTHER |
| Hainan Cancer Hospital |
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This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).
Eligible patients with high-risk locoregionally advanced NPC, defined as T4N1M0 disease, any T with N2-3M0 disease, stable disease (SD) or progressive disease (PD) after induction chemotherapy, or detectable plasma EBV DNA following induction chemotherapy, who have completed curative-intent chemoradiotherapy, will be randomly assigned to either the adjuvant Becotatug Vedotin group or the observation group. Participants assigned to the experimental group will receive Becotatug Vedotin at a dose of 2.3 mg/kg administered intravenously on Day 1 of each 21-day cycle for a total of three cycles. Participants assigned to the control group will undergo observation alone.
The primary endpoint is event-free survival (EFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), locoregional failure-free survival (LRFFS), and safety. All efficacy analyses will be performed in the intention-to-treat (ITT) population. Safety analyses will be conducted in the safety population, defined as all randomized patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Becotatug Vedotin | Experimental | Adjuvant therapy with Becotatug Vedotin |
|
| observation | No Intervention | Clinical follow-up and surveillance only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Becotatug Vedotin | Drug | This group will receive Becotatug Vedotin at a dose of 2.3 mg/kg on day 1 of each 3-week cycle for a total of 3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival | calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | calculated from the date of randomisation to death | 2 years |
| distant metastasis-free survival | calculated from the date of randomisation to the first distant metastasis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kai hu | Contact | +867715359801 | hukai@gxmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
| Affiliated Hospital of North Sichuan Medical College | OTHER |
| Lingshan people's Hospital | UNKNOWN |
| LiuZhou People's Hospital | OTHER |
| The Third people's hospital of Hechi | UNKNOWN |
| the second People's Hospital of qinzhou | UNKNOWN |
| Hunan Cancer Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Guangxi Nanxishan Hospital | UNKNOWN |
| Liuzhou Workers' Hospital | OTHER_GOV |
| Affiliated Hospital of Youjiang Medical University for Nationalitie | UNKNOWN |
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| 2 years |
| Locoregional failure-free survival | calculated from the date of randomisation to the first locoregional failure | 2 years |
| Treatment-Related Adverse Events | graded according to NCI CTCAE v5.0 | 2 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |