Becotatug Vedotin for Locoregionally Advanced Nasopharyngeal Carcinoma With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy: A Prospective, Single-Arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation and written informed consent must be signed.
- •Age between 18 and 70 years, male or non-pregnant female.
- •Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- •Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
- •Efficacy after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
- •ECOG performance status score of 0 or
- •Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010^9/L, and Platele (PLT) ≥10010^9/L.
- •Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
- •Adequate renal function: Serum creatinine ≤ 1.5*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- •International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 *ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
排除标准
- •Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- •Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- •Patients who have previously received radiotherapy or systemic chemotherapy.
- •Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
- •HIV positive.
- •History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
- •Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
研究组 & 干预措施
Experimental arm
- Induction Chemotherapy (TPP Regimen) Docetaxel 75 mg/m² d1 + Cisplatin (DDP) 75 mg/m² d1 + PD-1 inhibitor , administered every 3 weeks for a total of 3 cycles.
- Concurrent Radiotherapy (Becotatug vedotin + IMRT)
Concurrent radiotherapy commences 3 weeks after the completion of induction chemotherapy:
Becotatug vedotin 2.3 mg/kg d1, starting on the first day of radiotherapy, administered every 3 weeks during the radiotherapy period for a total of 3 cycles.
The radiotherapy technique employed is intensity-modulated radiotherapy (IMRT). 3. Adjuvant Therapy
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.
干预措施: Becotatug vedotin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
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.
次要结局
- Overall survival(3 years)
- Locoregional recurrence-free survival(3 years)
- Distant metastasis-free survival(3 years)
- Incidence of acute toxicity as assessed by CTCAE v5.0(3 years)
- Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group(3 years)
研究者
Pei-Yu Huang
Principal Investigator
Sun Yat-sen University