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Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

2026年7月7日 更新者：Lepu Biopharma Co., Ltd.

A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma

A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 尚未招聘
        • Peking University Cancer Hospital
        • 接触：
          • Bin Zhang
    • Fujian
      • Fuzhou、Fujian、中国、350005
        • 尚未招聘
        • The First Affiliated Hospital of Fujian Medical University
        • 接触：
          • Gongbiao Lin
    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • 招聘中
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • 接触：
          • Jinsong Li
      • Guangzhou、Guangdong、中国、510060
        • 尚未招聘
        • Sun Yat-sen University Cancer Center
        • 接触：
          • Xuekui Liu
      • Shantou、Guangdong、中国、515041
        • 尚未招聘
        • Cancer Hospital of Shantou University Medical College
        • 接触：
          • Hanwei Peng
    • Guangxi
      • Nanning、Guangxi、中国、530021
        • 尚未招聘
        • Guangxi Medical University Cancer Hospital
        • 接触：
          • Duoping Wang
    • Hebei
      • Shijiazhuang、Hebei、中国、050011
        • 尚未招聘
        • The Fourth Hospital of Hebei Medical University
        • 接触：
          • Juan Li
    • Hubei
      • Wuhan、Hubei、中国、430079
        • 尚未招聘
        • Hubei Cancer Hospital
        • 接触：
          • Jian Chen
    • Hunan
      • Changsha、Hunan、中国、410013
        • 尚未招聘
        • Hunan Cancer Hospital
        • 接触：
          • Hao Tian
      • Changsha、Hunan、中国、410008
        • 尚未招聘
        • Xiangya Hospital of Central South University
        • 接触：
          • Canhua Jiang
    • Liaoning
      • Shenyang、Liaoning、中国、110042
        • 尚未招聘
        • Liaoning Cancer Hospital & Institute
        • 接触：
          • Zhendong Li
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200120
        • 尚未招聘
        • Shanghai East Hospital
        • 接触：
          • Ye Guo
      • Shanghai、Shanghai Municipality、中国、200011
        • 尚未招聘
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • 接触：
          • Yue He
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310022
        • 尚未招聘
        • Zhejiang Cancer Hospital
        • 接触：
          • Chao Chen
      • Ningbo、Zhejiang、中国、315040
        • 尚未招聘
        • Ningbo Medical Center Lihuili Hospital
        • 接触：
          • Zhisen Shen

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Life expectancy ≥ 6 months.
  2. Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.
  3. At least one extracranial measurable lesion per RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  5. No severe cardiac dysfunction.
  6. Must provide tumor tissue sample not previously subjected to radiotherapy.
  7. Adequate organ function.
  8. Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.

Exclusion Criteria:

  1. Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).
  2. Head and neck cancer deemed non-resectable by the investigator.
  3. Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.
  4. Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.
  5. Major surgery within 4 weeks before study entry, or not fully recovered from surgical toxicities/complications. Minor procedures (e.g., vascular access placement, percutaneous/endoscopic head/neck biopsy, tracheostomy tube exchange) are allowed.
  6. Grade ≥2 peripheral neuropathy (CTCAE v5.0).
  7. Active autoimmune disease requiring systemic treatment within 2 years before first dose.
  8. Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose.
  9. Radiologically detectable central nervous system metastases and/or carcinomatous meningitis.
  10. Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion.
  11. Any severe or uncontrolled systemic disease.
  12. Prior or planned allogeneic tissue/solid organ transplantation.
  13. Known hypersensitivity to any active ingredient or excipient of the study drugs.
  14. Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  15. Anti-infective therapy within 2 weeks before randomization.
  16. Stroke or transient ischemic attack within 6 months before enrollment.
  17. Uncontrolled or poorly controlled cardiac disease.
  18. Deep or intraluminal bleeding requiring interventional/surgical hemostasis or blood transfusion within 3 months, or current history of coagulopathy.
  19. Pulmonary embolism or deep vein thrombosis within 3 months.
  20. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, bronchospasm, etc.
  21. Received live vaccine within 30 days before first study dose.
  22. History of other primary malignancy.
  23. Positive serum pregnancy test or breastfeeding female.
  24. Contraindications to study drugs (pucotenlimab and/or becotatug vedotin) or their excipients; severe hypersensitivity (Grade ≥3) to radiotherapy, cisplatin or its analogues.
  25. Any condition that the investigator considers unsuitable for participation in the trial.
  26. Grade ≥2 hearing impairment per CTCAE v6.0.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
药品：Becotatug Vedotin for Injection
Administrated intravenously
药品：Pucotenlimab Injection
Administrated intravenously
安慰剂比较：locally advanced resectable HNSCC Placebo +Pucotenlimab
药品：Pucotenlimab Injection
Administrated intravenously
药品：Placebo
Administrated intravenously

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Major Pathological Response (MPR) Rate
大体时间：From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
From date of surgery until completion of postoperative pathological assessment, up to 8 weeks

次要结果测量

结果测量
大体时间
Pathological Complete Response (pCR) Rate
大体时间：From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Event-Free Survival (EFS)
大体时间：From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
大体时间：From date of randomization until death from any cause, assessed up to 36 months
From date of randomization until death from any cause, assessed up to 36 months
Preoperative Objective Response Rate (ORR)
大体时间：preoperative ORR will be assessed up to 12 weeks post-randomization
preoperative ORR will be assessed up to 12 weeks post-randomization
actual surgical resection rate
大体时间：surgical resection rate will be evaluated perioperatively
surgical resection rate will be evaluated perioperatively
R0 resection rate
大体时间：R0 resection rate will be confirmed up to 8 weeks postoperatively
R0 resection rate will be confirmed up to 8 weeks postoperatively
lymph node downstaging rate
大体时间：lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
Incidence of adverse events (AEs) and laboratory abnormalities assessed by CTCAE v6.0
大体时间：Within 30 days after last dose (30 days + 7 days window)
Within 30 days after last dose (30 days + 7 days window)
Serum Concentration
大体时间：From randomization through completion of therapy, up to 30 weeks
From randomization through completion of therapy, up to 30 weeks
Incidence of Anti-Drug Antibodies (ADA)
大体时间：From randomization through completion of therapy, up to 30 weeks
From randomization through completion of therapy, up to 30 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lepu Biopharma Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月6日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年5月7日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HX008/MRG003-C004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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