Prospective Non-Randomized Phase II Study of Neoadjuvant Camrelizumab Combined With Paclitaxel and Carboplatin in Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity and Larynx (Stage III-IVA)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx.
Fifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg/m2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present).
The primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, <10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI/PET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls.
Study period: 2026-2029.
详细描述
Investigator-initiated, single-arm, phase II study conducted at P.A. Hertsen Moscow Oncology Research Institute. Protocol approved by Local Ethics Committee (#1187/132).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed squamous cell carcinoma of the oral cavity and/or larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)
- •Resectable disease planned for surgical treatment
- •Age 18-75 years
- •No prior antitumor therapy for the current diagnosis
- •Tumor sample available for PD-L1 expression assessment
- •No other malignancies in anamnesis (except basal cell carcinoma of skin and carcinoma in situ of cervix)
- •Absence of comorbidities preventing systemic chemotherapy and immunotherapy
排除标准
- •Patient refusal to undergo planned treatment
- •Protocol violations not related to medical indications
研究组 & 干预措施
Neoadjuvant Chemoimmunotherapy
Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.
Number of Participants: 50 (Anticipated)
干预措施: Camrelizumab (Drug)
Neoadjuvant Chemoimmunotherapy
Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.
Number of Participants: 50 (Anticipated)
干预措施: Paclitaxel (Drug)
Neoadjuvant Chemoimmunotherapy
Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.
Number of Participants: 50 (Anticipated)
干预措施: carboplatin (Drug)
Neoadjuvant Chemoimmunotherapy
Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.
Number of Participants: 50 (Anticipated)
干预措施: Radical Surgery (Procedure)
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: At the time of surgery (approximately 10-12 weeks from baseline)
Rate of complete pathological response (absence of viable tumor cells in resected specimen)
Major Pathological Response (MPR) Rate
时间窗: At the time of surgery (approximately 10-12 weeks from baseline)
Rate of major pathological response (\<10% viable tumor cells in resected specimen)
次要结局
- Objective Response Rate (ORR)(After 3 cycles of neoadjuvant therapy (approximately 9 weeks))
- 3-Year Event-Free Survival (EFS)(3 years from enrollment)
- Incidence of Adverse Events(From first dose until 30 days after surgery)
- Proportion Requiring Adjuvant Chemoradiation(At the time of surgery)