NCT04405154尚未招募2 期
A Phase II Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced, Unresectable 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
- 32
- 主要终点
- Objective Response Rate
研究概览
简要总结
The goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). All participants will receive camrelizumab in addition to chemoradiation, the standard treatment for LA-HNSCC.
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
- •Written informed consent
- •Has a pathologically proven new diagnosis of head and neck squamous cell carcinoma
- •Has unresectable disease and is eligible for definitive chemoradiation based on investigator decision
- •Has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on RECIST version 1.1
- •Has adequate organ function as defined
- •Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
- •Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
排除标准
- •Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
- •Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
- •Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
- •Has a history of severe hypersensitivity reaction to camrelizumab, Cisplatin or radiotherapy
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or has previously participated in clinical studies with camrelizumab
- •Has received a live vaccine within 30 days prior to the first dose of study therapy
- •Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
- •Has not recovered from major surgery prior to starting study therapy
- •Has known active Hepatitis B or C
- •Has known history of Human Immunodeficiency Virus (HIV)
- •Has a significant cardiovascular disease
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment
- •Has had previous allogeneic tissue/solid organ transplant
- •Has active infection requiring systemic therapy
- •Is pregnant or breast feeding
研究组 & 干预措施
Investigational Arm
Experimental
Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
干预措施: Camrelizumab (Biological)
Investigational Arm
Experimental
Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
干预措施: Cisplatin (Drug)
Investigational Arm
Experimental
Camrelizumab every 2 weeks in combination with 6-7 weeks of radiation therapy and every 3 weeks cisplatin.
干预措施: IMRT or VMAT (Radiation)
结局指标
主要结局
Objective Response Rate
时间窗: 6 months
The number of participants with radiologically confrmed complete or partial response according to RECIST 1.1
次要结局
- Overall Survival (OS)(Up to 5 years)
- Disease-free Survival (DFS)(Up to 5 years)
- Acute Adverse Events (AEs)(Up to 6 months)
研究者
相似试验
Unknown
不适用
Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric CancerAdvanced Gastric AdenocarcinomaNCT04675866Henan Cancer Hospital46
招募中
2 期
Study of Camrelizumab Plus Apatinib and Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)Triple Negative Breast CancerNCT05447702West China Hospital35
Unknown
2 期
A Study to Evaluate Camrelizumab in Combination With Nb-Paclitaxel in Patients With Advanced or Metastatic NSCLCNon-Small Cell Lung CancerNCT04167774Sun Yat-sen University62
Unknown
2 期
A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal CancerEsophageal CancerNCT04512417Zhejiang Cancer Hospital63
Unknown
2 期
Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT04547088Sun Yat-sen University27