A Randomized, Open-label, Multi-center Phase III Clinical Study of Toripalimab Combined With Cisplatin and Docetaxel Versus Toripalimab Alone as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 主要终点
- 2-year Event-Free Survival
研究概览
简要总结
This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.
Eligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).
We will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.
Taking part is voluntary and you can leave the study at any time.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed, newly diagnosed, non-metastatic, operable locally advanced head-and-neck squamous cell carcinoma (oral cavity, larynx, hypopharynx, or oropharynx) Stage III-IVA (p16-positive oropharynx T4N0-N2; p16-negative oropharynx III-IVA; larynx/hypopharynx/oral cavity III-IVA) PD-L1 CPS ≥ 1 Age 18-70 years ECOG performance status 0-1 Adequate organ function (ANC ≥ 2.0×10⁹/L, platelets ≥ 100×10⁹/L, TBIL < 1.5×ULN, ALT/AST < 1.5×ULN, creatinine < 1.5×ULN) No prior head-and-neck cancer surgery or radiotherapy No other malignancy within 5 years Signed informed consent
排除标准
- •Previous systemic anti-cancer therapy for head-and-neck cancer Known hypersensitivity to study drugs Active or untreated hepatitis B/C, HIV positivity Severe cardiac, pulmonary, liver, or renal insufficiency precluding surgery Pregnancy or lactation Psychiatric or social conditions preventing compliance Organ transplant on chronic immunosuppression
研究组 & 干预措施
Toripalimab monotherapy
Participants receive two 3-week cycles of toripalimab 240 mg IV before undergoing radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.
干预措施: Toripalimab (Drug)
Toripalimab + chemotherapy
Participants receive two 3-week cycles of toripalimab 240 mg IV combined with docetaxel 75 mg/m² and cisplatin 75 mg/m² before radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.
干预措施: Docetaxel and Cisplatin (Drug)
Toripalimab + chemotherapy
Participants receive two 3-week cycles of toripalimab 240 mg IV combined with docetaxel 75 mg/m² and cisplatin 75 mg/m² before radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.
干预措施: Toripalimab (Drug)
结局指标
主要结局
2-year Event-Free Survival
时间窗: From randomisation to 24 months
Proportion of patients alive and free from locoregional recurrence, distant metastasis, second primary tumor, or death from any cause within 24 months after randomisation, assessed per modified RECIST 1.1.
2-year Event-Free Survival (EFS)
时间窗: From randomisation to 24 months
Proportion of patients alive and free from locoregional recurrence, distant metastasis, second primary tumor, or death from any cause within 24 months after randomisation, assessed per modified RECIST 1.1.
次要结局
未报告次要终点
研究者
Xuekui Liu
Chief Physician, Department of Head and Neck Surgery, Sun Yat-sen University Cancer Center; Principal Investigator of the SHINE Study
Sun Yat-sen University