NCT07445048招募中3 期
A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2026年3月4日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS
研究概览
简要总结
A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.
The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age > 70 years;② Renal insufficiency (creatinine clearance < 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy > Grade 1;⑥ Patient refusal of chemotherapy.
- •Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative/unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.
- •Underwent radical surgery with at least one high-risk feature:
- •Extracapsular extension (ECE) of lymph node metastasis; Close margin (< 1 mm) or positive margin;
- •4 metastatic lymph nodes, or multiple perineural invasions.
- •No evidence of distant metastasis on imaging.
- •Sufficient tumor tissue available for EGFR and PD-L1 testing; for oropharyngeal cancer, HPV/p16 testing is required (testing may be waived if results are already available).
- •Expected survival ≥ 6 months.
- •ECOG performance status 0-
- •Adequate hematologic function:
- •WBC ≥ 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- •Adequate renal function:Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) > 50 mL/min (calculated by Cockcroft-Gault formula):
- •Female: CrCl = (140 - Age) × Weight (kg) × 0.85 / (72 × Scr (mg/dL)) Male: CrCl = (140 - Age) × Weight (kg) × 1.00 / (72 × Scr (mg/dL))
- •Adequate hepatic function:
- •Total bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN.
- •Women of childbearing potential: negative serum or urine pregnancy test within 14 days before enrollment, and agreement to use effective contraception during the study.Male subjects: use effective contraception from the start of treatment until 180 days after the last study drug administration.
- •Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.
排除标准
- •Prior radiotherapy for head and neck cancer before enrollment.
- •Prior treatment with similar immunological or targeted agents.
- •Participation in another interventional clinical trial within 30 days prior to screening.
- •Evidence of distant metastasis.
- •History of other malignancy within the previous 5 years, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized differentiated thyroid cancer (papillary / follicular), localized prostate cancer, and ductal carcinoma in situ.
- •Uncontrolled concurrent medical conditions (e.g., heart failure, diabetes mellitus, hypertension, thyroid disease, psychiatric disorders, etc.).
- •Known HIV infection, active viral hepatitis, or active tuberculosis.
- •Major surgical procedure within 30 days before the first dose of study medication, or planned major surgery during the study.
- •Hypersensitivity to any study drug or their components.
- •Pregnancy (confirmed by serum or urine HCG test) or lactating women; subjects of childbearing potential unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last study treatment.
- •Subjects considered inappropriate for study participation by the investigator.
- •Subjects unwilling to participate in the study or unable to provide written informed consent.
研究组 & 干预措施
Control Group
Active Comparator
干预措施: radiotherapy (Radiation)
Study Group
Experimental
干预措施: radiotherapy (Radiation)
Study Group
Experimental
干预措施: Nimotuzumab (Drug)
Study Group
Experimental
干预措施: Bemcentinib (Drug)
Control Group
Active Comparator
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Disease-Free Survival (DFS
时间窗: From enrollment until disease recurrence, metastasis, second primary cancer, or death from any cause, assessed up to 3 years after last patient enrolled
次要结局
- Overall Survival (OS)(From enrollment until death from any cause, assessed up to 3 years after last patient enrolled)
- Locoregional Recurrence-Free Survival (LRRFS)(From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled)
- Distant Metastasis-Free Survival (DMFS)(From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled)
- Change From Baseline in Global Quality of Life Score (EORTC QLQ-C30)(Up to 24 months.)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).])
- Change From Baseline in Head and Neck-Specific Quality of Life Score (EORTC QLQ-H&N35)(Up to 24 months)
研究者
Guopei Zhu
Professor, Chief Physician
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
研究点 (1)
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