NCT07432087尚未招募3 期
Randomized Controlled Trial of Camrelizumab Combined With EGFR Monoclonal Antibody or Chemotherapy for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Yue He, MD0 个研究点目标入组 246 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 主要终点
- 2-year Overall Survival (OS) Rate
研究概览
简要总结
This is a prospective, randomized, controlled, multicenter, non-inferiority clinical study designed to evaluate the efficacy and safety of camrelizumab combined with EGFR monoclonal antibody or chemotherapy as perioperative treatment of locally advanced head and neck squamous cell carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal cancer);
- •Aged 18-75 years, of any gender
- •Subjects in clinical stage III-IVb (TNM staging, 8th edition); for oropharyngeal squamous cell carcinoma (P16-), the stage shall be III-IVb; for oropharyngeal squamous cell carcinoma (P16+), the stage shall be III.
- •Subjects with no prior anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy, or biotherapy for the current head and neck tumors;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Estimated survival time ≥ 6 months;
- •Subjects with no obvious contraindications to immunotherapy, chemoradiotherapy and surgery;
- •Subjects who are willing to undergo surgical treatment;
- •Subjects with major organ function levels meeting the following criteria:
- •Hematology must meet the following criteria: White blood cell (WBC) count ≥4.0×10^9/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet (PLT) count ≥100×10^9/L, hemoglobin (Hb) ≥90 g/L (no blood transfusion or blood products within 14 days, and no correction with granulocyte-colony stimulating factor (G-CSF) or other hematopoietic stimulating factors);
- •Blood chemistry must meet the following criteria: Serum albumin ≥ 3.0 g/dL (30 g/L), total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, blood urea nitrogen (BUN) and creatinine (CRE) ≤1.5×ULN or endogenous creatinine clearance ≥60 mL/min (Cockcroft-Gault formula);
- •Good coagulation function: Defined as an international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; if the subject is receiving anticoagulant therapy, the PT must be within the intended therapeutic range for the anticoagulant drug;
- •Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and be willing to use effective methods of contraception during the study and for 6 months after the last dose of the anti-PD-1 antibody. For male subjects whose partners are women of childbearing potential, effective methods of contraception must be used during the study and for 6 months after the last dose of the anti-PD-1 antibody;
- •Subjects who voluntarily participate in this study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.
排除标准
- •Subjects who have received prior treatment with anti-PD-1/programmed death-ligand 1 (PD-L1) antibodies, anti-programmed death-ligand 2 (PD-L2) antibodies, anti-cluster of differentiation 137 (CD137) antibodies, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways;
- •Subjects with a severe, active autoimmune disease. Subjects in a stable condition who do not require systemic immunosuppression are allowed to be enrolled, such as those with: Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia);
- •Subjects with congenital or acquired immunodeficiency (e.g., human immunodeficiency virus (HIV) infection), active hepatitis B (hepatitis B virus (HBV)-DNA ≥10^4 copies/mL), or active hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method);
- •Subjects with known allergy to the study drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies.
- •Subjects with the following conditions within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, cardiac insufficiency of NYHA Class II or higher, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure.
- •Subjects who have received a live vaccine within 4 weeks before the first dose of the study drug. Inactivated virus vaccines for seasonal influenza administered by injection are permitted, but live attenuated influenza vaccines administered nasally are not permitted;
- •Subjects with known history of allogeneic organ transplant or allogeneic stem cell transplant.
- •Subjects with known history of psychoactive drug abuse or drug addiction.
- •Pregnant or lactating women;
- •Subjects with diagnosis of any other malignant tumors within 5 years prior to study entry, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid cancer that have been locally treated and cured;
- •Subjects with other serious physical or mental illnesses or laboratory test abnormal findings that may increase the risk of study participation, or interfere with study results, and patients whom the investigator deems unsuitable for participation in this study.
研究组 & 干预措施
Camrelizumab and Cetuximab
Experimental
Camrelizumab (Day 1) and Cetuximab Beta (Day 1, Day 8, Day 15), 2 cycles
干预措施: Camrelizumab and Cetuximab (Drug)
Camrelizumab and Chemotherapy
Active Comparator
Camrelizumab (Day 1), Paclitaxel Albumin - bound (Day 1, Day 8) and Carboplatin (Day 1), 2 cycles
干预措施: Camrelizumab and Chemotherapy (Drug)
结局指标
主要结局
2-year Overall Survival (OS) Rate
时间窗: 2 years from the date of randomization
It is defined as the proportion of patients who remain alive at 2 years from the date of randomization, relative to the total number of patients in the group (Intention-to-Treat, ITT population).
次要结局
- 2-year Event-Free Survival (EFS) Rate(2 years from the date of randomization)
- Pathologic Complete Response (pCR) Rate(Within 1 month after surgery)
- Major Pathologic Response (MPR) Rate(Within 1 month after surgery)
- Objective Response Rate (ORR) assessed by RECIST 1.1(Perioperative)
- 3-year and 5-year Event-free Survival (EFS) Rates(3 years and 5 years from the start of randomization)
- 3-year and 5-year Overall Survival (OS) Rates(3 years and 5 years from the start of randomization.)
- Quality of Life (QoL) Assessment by EORTC QLQ-C30(Perioperative)
- Quality of Life (QoL) Assessment by H&N35(Perioperative)
- Adverse Events (AEs)(Baseline and Week 4)
研究者
Yue He, MD
Director of Oral and Maxillofacial & Head and Neck Oncology Department , Principal Investigator, Clinical Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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