NCT04861467尚未招募2 期
A Randomized, Open Study of Camrelizumab vs Placebo as a Maintenance Therapy After Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- median progression-free survival(in accordance with RECIST1.1)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.
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
- •Who have histologic or cytologic confirmation of head and neck squamous cell carcinoma in the mouth, oropharynx (p16-), hypopharynx, or larynx.
- •Local advanced head and neck squamous cell carcinoma diagnosed as stage III-IVa by AJCC 8
- •Except for the prescribed radical radiotherapy and chemotherapy regimen, there has been no previous treatment for LA-HNSCC systemic antitumor or local radical therapy (allowing the prescribed induction chemotherapy regimen before radical radiotherapy and chemotherapy)
- •28 days after radical radiotherapy and chemotherapy (radiotherapy and chemotherapy (±7 days) did not show disease progression, and consideration was given within 28 days after curative effect evaluation
- •Clinically assessable lesions according to RECIST1.1,(lesion length ≥10 mm or lymph node short diameter ≥15 mm)
- •The age at which informed consent is signed is 18-70 years, male and female
- •KPS score ≥80 percent
- •Estimated lifetime ≥6 months
- •The function of important organs meets the following requirements (excluding the use of any blood components and cytokines within 14 days):
- •Normal bone marrow reserve function: WBC≥3.0×10^9/ L, NEUT≥1.5×10^9/ L, PLT≥80×10^9/ L, Hb≥90g/L Normal renal function or SCr≤1.5 times normal upper limit (ULN) or Ccr≥50 ml/min ; Normal liver function or TBIL≤1.5 times the upper limit of normal value (ULN); AST or ALT level 2.5 times the upper limit of normal value (ULN);
- •Ability and willingness to follow research and follow-up procedures
- •Men and women of childbearing age must agree to adequate contraception throughout the study period and within 6 months after treatment
- •The subjects volunteered to join the clinical study and signed informed consent, good compliance and follow-up
排除标准
- •1.Have received any systemic anti-tumor therapy against the target lesion
- •Previous experience in head and neck radiotherapy
- •Previous immunotherapies including anti PD-1/PD-L1, anti CTLA-4, etc
- •Subjects who received anti-tumor vaccines or other immunomodulatory drugs (e.g. interleukin-2, thymosin, Lentinus edodes polysaccharide, etc.) within 1 month prior to joining the group, or who received live attenuated vaccines
- •Subjects who had been systematically treated with corticosteroids (prednisone or other equivalent hormones >10 mg/ days) or other immunosuppressants within 1 month of entry. To allow inhaled or local use of corticosteroids in the absence of active autoimmune disease, as well as adrenocorticotropic replacement therapy ≤10 days mg/ dose of prednisone
- •Pleural effusions, pericardial effusions or ascites requiring drainage, or serosal effusions for treatment within 2 weeks prior to group entry
- •No active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary, vasculitis, nephritis, hyperthyroidism, hypothyroidism) may be included
- •Subjects with severe infection within 1 month prior to admission, including, but not limited to, infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection, or unexplained fever >38.5℃ during screening, prior to first administration
- •Severe cardiovascular disease: grade II myocardial ischemia or myocardial infarction, uncontrolled arrhythmia; grade III ~ IV cardiac insufficiency, or echocardiography indicated that left ventricular ejection fraction (LVEF)<50%;
- •The subjects were treated with bronchiectasis and other systemic treatments. Asthma control was unsatisfactory and could not be included (asthma was completely alleviated in childhood and included without any intervention in adults)
- •HIV infection or known AIDS, active hepatitis B (HBV DNA≥500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
- •Subjects with a history of other malignancies within five years (except complete treatment of skin cancer with cervical or basal cell carcinoma or squamous cell carcinoma in situ)
- •Patients with a clear history of allergies may be allergic to, or intolerant to Camrelizumab
- •Persons with a history of substance abuse and who are unable to abstain or who have mental disorders Increasing the risk associated with participating in a study or research drug and, according to the researcher's judgment, other circumstances in which the subjects are not suitable for inclusion in the study
研究组 & 干预措施
Experimental: Camrelizumab
Experimental
camrelizumab as maintenance therapy after Chemoradiation(evaluation results：PR/SD)
干预措施: Camrelizumab (Drug)
Exploration：Camrelizumab
Experimental
camrelizumab for maintenance after chemoradiation( evaluation results：CR)
干预措施: Camrelizumab (Drug)
结局指标
主要结局
median progression-free survival(in accordance with RECIST1.1)
时间窗: Up to 3 years
mPFS is the median time from the date of randomization to the date of first record of disease progression or death.
次要结局
- 1 year progression-free survival rate(1 year from the the date of randomization)
- overall survival(Up to 3 years)
- disease control rate(Up to 3 years)
- objective response rate(Up to 3 years)
- time to progression(Up to 3 years)
- progression-free survival(in accordance with irRECIST1.1)(Up to 3 years)
研究者
Jun-Lin Yi, MD
Professor
Chinese Academy of Medical Sciences
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric CancerGastric CancerNCT04345783Beijing Friendship Hospital30
已完成
3 期
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)Triple Negative Breast CancerNCT04613674Jiangsu HengRui Medicine Co., Ltd.441
招募中
2 期
A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCCEsophageal CancerNCT05182944The First Affiliated Hospital of Zhengzhou University130
招募中
不适用
A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric CancerRWSGastric CancerPD-1 ImmunotherapyNCT06485271Changzhi People's Hospital Affiliated to Changzhi Medical College504
尚未招募
2 期
Study of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)Triple Negative Breast CancerNCT04907344Tianjin Medical University Cancer Institute and Hospital420