NCT04291092Unknown2 期
Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- 6 month progression-free survival rate
研究概览
简要总结
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.
详细描述
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG is 0-1;
- •Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
- •The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
- •According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
- •Sign informed consent and agree to collect the clinical efficacy and information of the patient.
排除标准
- •Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
- •Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
- •Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
- •Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
- •History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
- •Patients with interstitial lung disease or previous history of interstitial pneumonia;
- •Having a history of substance abuse and unable to abstain from it or having mental disorders;
- •who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
- •Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
- •previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
- •(a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
- •The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
研究组 & 干预措施
single-arm
Experimental
single-arm
干预措施: Immunotherapy (Drug)
single-arm
Experimental
single-arm
干预措施: WBRT (Radiation)
single-arm
Experimental
single-arm
干预措施: Chemotherapy (Drug)
结局指标
主要结局
6 month progression-free survival rate
时间窗: 6 month
6 month progression-free survival rate
次要结局
未报告次要终点
研究者
GongLei
Professor
Zhejiang Cancer Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Phase II Clinical Study of Camrelizumab Combined With Chemotherapy or Anlotinib in Advanced Esophageal Squamous Cell CancerStage IV Esophagus Squamous Cell CarcinomaNCT05322499Zhejiang Cancer Hospital80
Unknown
不适用
A Study of Camrelizumab Combined With Chemotherapy Sequential Camrelizumab Combined With Apatinib Treatment of Advanced NSCLCNon-small Cell Lung CancerNCT04950400Beijing Chest Hospital60
招募中
2 期
Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLCEarly Stage Non-small Cell Lung CancerNCT04530227Tianjin Medical University Cancer Institute and Hospital30
招募中
2 期
Neoadjuvant Therapy of Camrelizumab Combined With Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell CarcinomaEsophageal CarcinomaNCT05476380Tianjin Medical University Cancer Institute and Hospital39
撤回
不适用
A Trial of Camrelizumab Combined With Ablation and Chemotherapy in Patients With Pancreatic Cancer Liver Metastasis（SHR-1210-HLJ-009）Liver MetastasisPancreatic CancerNCT04420130Yanqiao Zhang