A Multicenter, Randomized Controlled Clinical Trial of Finotonlimab Combined With Chemotherapy as Perioperative Therapy for Untreated Stage II Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
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
- •Age 18-75 years
- •Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
- •Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable
- •ECOG sccore 0-1
- •No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for the current head and neck tumor
- •Willing to undergo surgical treatment
- •No significant contraindications to immunotherapy, radiotherapy, or chemotherapy
- •Major organ function meets the following criteria: a) Hematologic: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L (no blood transfusion or blood products, no G-CSF or other hematopoietic growth factors within 14 days); b) Biochemistry: serum albumin ≥ 3.0 g/dL (30 g/L), TBIL ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) Adequate coagulation: defined as INR or PT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, PT within the intended therapeutic range of the anticoagulant is acceptable
- •Both male and female subjects are eligible; women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody
- •The subject voluntarily enrolls in this study, signs the informed consent form, demonstrates good compliance, and cooperates with follow-up
排除标准
- •Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways
- •Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
- •Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)
- •Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies
- •Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA class ≥ 2 cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure
- •Receipt of a live vaccine within 4 weeks prior to the first dose of study drug; inactivated influenza vaccine administered by injection is permitted, while intranasal live attenuated influenza vaccine is not permitted
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- •Known history of psychotropic substance abuse or drug addiction
- •Pregnant or lactating women
- •Diagnosis of any other malignancy within 5 years prior to study entry, except for curatively treated localized cancers including basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma
- •Any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for study participation in the opinion of the investigator
研究组 & 干预措施
Upfront Surgery
Participants undergo upfront surgery. Based on postoperative pathological risk factors, participants may receive postoperative radiotherapy or concurrent chemoradiotherapy.
干预措施: Surgery (Procedure)
Neoadjuvant Finotonlimab Plus Chemotherapy
Participants receive two 3-week cycles of neoadjuvant finotonlimab plus nab-paclitaxel and carboplatin or cisplatin, followed by surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be given based on pathological risk factors. Participants also receive six 3-week cycles of postoperative finotonlimab maintenance therapy.
干预措施: Neoadjuvant Finotonlimab Plus Chemotherapy (Drug)
Neoadjuvant Finotonlimab Plus Chemotherapy
Participants receive two 3-week cycles of neoadjuvant finotonlimab plus nab-paclitaxel and carboplatin or cisplatin, followed by surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be given based on pathological risk factors. Participants also receive six 3-week cycles of postoperative finotonlimab maintenance therapy.
干预措施: Surgery (Procedure)
Neoadjuvant Finotonlimab Plus Chemotherapy
Participants receive two 3-week cycles of neoadjuvant finotonlimab plus nab-paclitaxel and carboplatin or cisplatin, followed by surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be given based on pathological risk factors. Participants also receive six 3-week cycles of postoperative finotonlimab maintenance therapy.
干预措施: Postoperative Finotonlimab Maintenance (Drug)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: 2 years after randomization
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.
次要结局
- Overall Survival (OS)(2 years after randomization)
- Major Pathological Response (MPR) Rate(Within 2 weeks after surgery)
- Pathologic Complete Response (pCR) Rate(Within 2 weeks after surgery)
- 5-Year Overall Survival (OS)(5 years after randomization)
- 5-Year Event-Free Survival (EFS)(5 years after randomization)
- 2-Year Distant Metastasis-Free Survival (DMFS)(2 years after randomization)
- 5-Year Distant Metastasis-Free Survival (DMFS)(5 years after randomization)
- 2-Year Locoregional Recurrence-Free Survival (LRFS)(2 years after randomization)
- 5-Year Locoregional Recurrence-Free Survival (LRFS)(5 years after randomization)
- Incidence of Adverse Events(From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.)
研究者
Yanjie Zhang, MD
Professor and Chief Physician
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University