A Multicenter, Randomized, Phase II Clinical Trial to Optimize the Timing of Immune Checkpoint Inhibitor Administration During Neoadjuvant Chemotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 198
- 主要终点
- Complete Response Rate
研究概览
简要总结
This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.
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
- •Age between 18 and 70 years
- •Histologically confirmed locoregionally advanced nasopharyngeal carcinoma (AJCC/UICC 8th edition stage II-III)
- •At least one measurable target lesion per RECIST 1.1
- •ECOG performance status of 0-1
- •Estimated life expectancy ≥ 6 months
- •Adequate hematologic, hepatic, renal, and coagulation function
- •Negative pregnancy test for women of childbearing potential
- •Willingness to use effective contraception during the study and for 12 months after treatment
- •Signed informed consent
- •Willing and able to comply with study procedures
- •Not participating in any other interventional clinical trials during the study period
排除标准
- •re first dose
- •Active or suspected autoimmune disease requiring systemic treatment
- •Ongoing systemic immunosuppressive therapy
- •Active hepatitis B, hepatitis C, HIV infection, or other serious infections
- •History of another malignancy within 5 years (except non-melanoma skin cancer or in situ cervical cancer)
- •Pregnant or breastfeeding women
- •Inability or unwillingness to use contraception as required
- •Life expectancy < 6 months
研究组 & 干预措施
Control Arm
Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 of each 21-day cycle for 3 cycles.
Experimental Arm
Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 9 of each 21-day cycle for 3 cycles.
干预措施: Toripalimab (Drug)
Exploratory Arm
Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 5 of each 21-day cycle for 3 cycles. This arm is exploratory in nature with a smaller sample size.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
The proportion of participants achieving complete response (CR) after 2 cycles of neoadjuvant chemotherapy combined with toripalimab, as assessed by RECIST or institutional imaging criteria.
次要结局
- Objective Response Rate(After 2 cycles of neoadjuvant therapy (21-28 days for each cycle))
- Disease Control Rate(After 2 cycles of neoadjuvant therapy (21-28 days for each cycle))
- EBV DNA Clearance Rate(After 2 cycles of neoadjuvant therapy (21-28 days for each cycle))
- Incidence of Grade ≥3 Treatment-Related Adverse Events(From first dose until 30 days after the end of neoadjuvant therapy)
研究者
Huang Chaobin
Professor
Fujian Cancer Hospital