NCT06170710招募中2 期
Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Disease free survival at year 2 (2y-DFS)
研究概览
简要总结
This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).
详细描述
This open-label, randomized, controlled, phase II study will include 173 patients who have been operated for their LA SCCHN with high risk.
Subjects will be randomized (1:1) to receive post-operative concomitant cisplatin-RT followed by/not PD-1 antibody.
The study is designed with the general objective of demonstrating that treatment CCRT followed by PD-1 antibody is more efficient than CCRT alone.
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
- •Histologically proven squamous cell carcinoma of the head and neck which include but not limit following primary sites: oral cavity, oropharynx, hypopharynx or larynx
- •Patients eligible with one or more High-Risk factors of the following: For HPV+ OPSCC: T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion；For HPV- HNSCC：T4 OR cN3 OR pN2 OR non-R0 resection OR resection margin<5mm OR ENE (+) OR perineural invasion OR vessel/lymphatic vessel invasion OR IV/V cervical lymph node metastases
- •ECOG performance score 0-1
- •PD-L1 expression with CPS>1
- •No contraindications to immunotherapy or chemoradiotherapy
- •Adequate organ function
- •Female subject of childbearing potential should have a negative pregnancy test within 7 days prior to receiving the first dose of study medication.Female subjects of childbearing potential must be willing to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
- •Reproductive male subjects must agree to use an adequate method of contraception during the course of the study and 60 days after the last dose of study medication.
- •Informed consent is obtainable.
排除标准
- •Previous or co-existing malignancies, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer
- •Active infection
- •Known active viral infection Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV
- •Active and/or historical autoimmune disease, except patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood
- •Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- •Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study
- •History of PD-1/L1 treatment
- •If the subjects underwent major surgery for non-tumors, the toxicity and complications of the surgery needed to be adequately treated and the body conditions returned to normal
- •Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
- •Other circumstances leading to the termination of the study, as determined by the investigator
研究组 & 干预措施
RT+ cisplatin+Anti-PD-1 antibody
Experimental
Concurrent cisplatin-RT followed by PD-1 antibody
干预措施: Anti-PD-1 monoclonal antibody (Drug)
RT+ cisplatin+Anti-PD-1 antibody
Experimental
Concurrent cisplatin-RT followed by PD-1 antibody
干预措施: Postoperative CCRT (Other)
RT+ cisplatin
Active Comparator
Concurrent cisplatin-RT
干预措施: Postoperative CCRT (Other)
结局指标
主要结局
Disease free survival at year 2 (2y-DFS)
时间窗: From randomization until time of events up to 2 years
Disease-free survival time is defined as the time from date of randomization until the first disease recurrence（including carcinoma in situ）or death from any cause.
次要结局
- Locoregional control at year 2 (2y-LRC)(From randomization until time of events up to 2 years)
- Overall survival at year 2 (2y-OS)(From randomization until death due to any cause, up to 2 years)
- Adverse events(From randomization until time of events up to 2 years)
研究者
研究点 (1)
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