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Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA >0 copies/mL or imaging response evaluation showing SD/PD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival. Based on the above research and background, the investigators plan to conduct the first prospective, single-arm, phase II clinical study of becotatug vedotin in patients with locally advanced nasopharyngeal carcinoma who are suboptimal responsive to immuno-induction chemotherapy, aiming to obtain sufficient evidence-based medical data to provide an additional treatment option for the concurrent and adjuvant phases of nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental |
Adjuvant therapy commences 4-6 weeks after the completion of radiotherapy: Becotatug vedotin 2.3 mg/kg d1, administered every 3 weeks for a total of 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Becotatug vedotin | Drug | Becotatug vedotin during concurrent radiotherapy and the adjuvant phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival is calculated from the date of treatment initiation to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is calculated from the date of treatment initiation to death from any cause. | 3 years |
| Locoregional recurrence-free survival | Locoregional recurrence-free survival is calculated from the date of treatment initiation to the date of documented locoregional recurrence or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pei-Yu Huang | Contact | +86-20-87343379 | huangpy@sysucc.org.cn | |
| Qi Yang | Contact | yangqi@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Becotatug vedotin | Drug |
Adjuvant therapy commences 4-6 weeks after the completion of radiotherapy: Becotatug vedotin 2.3 mg/kg d1, administered every 3 weeks for a total of 3 cycles. |
|
| 3 years |
| Distant metastasis-free survival | Distant metastasis-free survival is calculated from the date of treatment initiation to the date of documented distant metastasis or death from any cause. | 3 years |
| Incidence of acute toxicity as assessed by CTCAE v5.0 | Acute adverse events (those that occurred within 1 year of randomisation) are graded according to the Common Terminology Criteria for Adverse Events (version 5.0). | 3 years |
| Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group | Late adverse events (those occurring >1 year after randomisation) are graded according to the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group. | 3 years |