NCT07791745尚未招募2 期
A Prospective, Multicenter, Randomized, Controlled Phase II/III Study to Evaluate the Efficacy and Safety of Enlituo® Plus Anyouping® and Platinum-Based Chemotherapy Versus Anyouping® Plus Platinum-Based Chemotherapy as First-Line Treatment for Advanced, Recurrent or Metastatic of the Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Overall Survival (Phase 3)
研究概览
简要总结
A Clinical Trial Comparing the Efficacy and Safety of Anyouping® and Platinum-based Chemotherapy With Enlituo® in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
详细描述
This study is a Phase II/III clinical trial, aimed to evaluate the efficacy and safety of Enlituo® combined with Anyouping® plus platinum and nab-paclitaxel chemotherapy as first-line therapy for advanced, recurrent or metastatic HNSCC.
Phase II Part Approximately 60 participants will be enrolled and randomly assigned at a 1:1 ratio to the experimental group.
Phase III Part Approximately 302 participants will be enrolled and randomly assigned in a 1:1 double-blind manner to the experimental group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the written informed consent form and be willing to comply with all requirements specified in the study protocol;
- •Aged ≥ 18 years;
- •Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (including oral cavity, oropharynx, hypopharynx, larynx), deemed incurable after local therapy;
- •Have not received any systemic therapy for recurrent or metastatic disease. Note: If disease progression occurs during neoadjuvant/adjuvant therapy, concurrent radiotherapy, or within 6 months after treatment discontinuation, the anti-tumor therapy administered during neoadjuvant/adjuvant therapy or concurrent radiotherapy (including platinum-based chemotherapy, anti-EGFR monoclonal antibodies, PD-1/PD-L1 inhibitors, etc.) will be regarded as first-line systemic therapy, and such subjects will be excluded.
- •(Remark: Subjects previously treated with PD-1/PD-L1 inhibitors may be enrolled provided a washout period of ≥ 12 months is met.)
- •Have at least one measurable evaluable target lesion per RECIST v1.1, or a measurable lesion with definitive radiological progression following local therapy, and the lesion must be suitable for repeated precise measurement;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no disease deterioration within 2 weeks prior to enrollment;
- •For participants with oropharyngeal carcinoma, human papillomavirus (HPV) status test results based on tumor tissue samples must be available prior to enrollment.
排除标准
- •Primary tumor site (any histologic type) located in nasopharynx, nasal cavity, paranasal sinus, salivary gland, thyroid or parathyroid gland, skin, or unknown primary origin;
- •Participants who have been diagnosed with a malignancy other than squamous cell carcinoma of the head and neck within 3 years prior to enrollment. Exceptions include cured basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ of the cervix and/or breast cancer treated with curative resection;
- •Participants with an expected survival of less than 6 months and/or rapidly progressive disease (e.g., participants experiencing rapid disease progression within 1-2 months during therapy planned prior to enrollment);
- •Participants eligible for curative-intent local therapy;
- •Pregnant or breastfeeding participants, or those planning pregnancy or conception during the anticipated study period (from screening visit through 180 days after the last dose);
- •Known history of psychiatric disorder or substance abuse that would interfere with compliance with study requirements;
- •Any other condition that renders the participant unsuitable for enrollment in the opinion of the investigator.
研究组 & 干预措施
Enlituo®
Experimental
干预措施: Enlituo® + Anyouping® + PBC (Drug)
Placebo
Placebo Comparator
干预措施: Placebo-Enlituo + Anyouping® + PBC (Drug)
结局指标
主要结局
Overall Survival (Phase 3)
时间窗: Up to 2 years.
Objective Response Rate (Phase 2)
时间窗: Up to 2 years.
次要结局
- Duration of response(Up to 2 years.)
- Disease control rate(Up to 2 years.)
- Progression-Free Survival(Up to 2 years.)
- Objective Response Rate (Phase 3)(Up to 2 years.)
- Overall Survival (Phase 2)(Up to 2 years.)
- Time to Progression(Up to 2 years.)
- Number of participants with treatment-related adverse events as assessed by CTCAE v6.0(From the date of informed consent signature until 28 days after the last dose (each cycle is 21 days, up to 35 cycles or 2 years).)
研究者
研究点 (1)
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