Becotatug Vedotin Versus Capecitabine as Adjuvant Therapy for Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Kai Hu
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- failure-free survival
概览
简要总结
This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to compare the efficacy and safety of Becotatug Vedotin and capecitabine as an adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).
详细描述
Eligible patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), staged as T4 N1 M0 or T any N2-3 M0, who have completed curative chemoradiotherapy, will be randomized to either an metronomic capecitabine group or an adjuvant Becotatug Vedotin group. Participants in 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 in the control group will receive metronomic capecitabine at a dose of 650 mg/m² orally twice daily for one year. The primary endpoint is failure-free survival (FFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (D-MFS), locoregional failure-free survival (LR-FFS), and treatment-emergent adverse events. All efficacy analyses will be performed on an intention-to-treat (ITT) basis. Safety analyses will be conducted in the safety population, defined as all patients who received at least one dose of the assigned study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- •Original clinical staged as TanyN2-3M0 or T4N1M0 (according to AJCC 9th edition), with no evidence of distant metastasis.
- •ECOG performance status ≤
- •Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.
- •No later than 6 weeks after the completion of the last radiotherapy treatment.
- •Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min)
- •Patients must be informed of the investigational nature of this study and give written informed consent.
- •Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
排除标准
- •Patients who could not tolerate or were allergic to Becotatug Vedotin.
- •Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal, or antiviral therapy before randomization, including but not limited to tuberculosis infection.
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- •Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.
- •Patients who are known to be intolerant or sensitive to any therapeutic agents.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
研究组 & 干预措施
Adjuvant Becotatug Vedotin
Adjuvant therapy with Becotatug Vedotin
干预措施: Becotatug Vedotin (Drug)
control
metronomic capecitabine
干预措施: capecitabine (Drug)
结局指标
主要结局
failure-free survival
时间窗: 2 years
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
次要结局
- overall survival(2 years)
- Locoregional failure-free survival(2 years)
- distant metastasis-free survival(2 years)
- treatment-related adverse events (AEs)(5 years)
研究者
Kai Hu
professor
Guangxi Medical University