NCT04118933Unknown2 期
An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer
Xu jianmin1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
To observe the efficacy of PD-1 antibody JS001 in the treatment of participants with microsatellite instability-high (MSI-H) advanced or recurrent colorectal cancer, so as to provide sufficient evidence for MSI-H as a biomarker of PD-1/PD-L1 inhibitor.
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
- •Fully understand the study and sign informed consent voluntarily;
- •Histologically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;
- •Patients who have previously received first-line or above chemotherapy or targeted therapy and failed to the treatment or experienced recurrence;
- •At least one measurable lesion (RECIST 1.1);
- •Agree to provide tumor tissue samples and Pathology reports related to the specimens;
- •Aged 18 to 75 years, gender not limited;
- •Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1;
- •Expected survival ≥3 months;
- •Laboratory test values must meet the following standards within 7 days before enrollment;
- •Women of reproductive age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use
排除标准
- •Uncontrolled or symptomatic hypercalcemia;
- •Had major surgery or had not fully recovered from previous surgery within 4 weeks before enrollment;
- •central nervous system(CNS) metastases;
- •Bone metastases;
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allow the patient to have a catheter indwelling;
- •Having a history of idiopathic pulmonary fibrosis, organic pneumonia;
- •Uncontrolled active infection, including but not limited to acute pneumonia;
- •Have other malignant tumors at the same time;
- •The patient has any active autoimmune diseases or a history of autoimmune diseases;
- •Liver diseases of known clinical significance, including active viral viral hepatitis, alcoholic hepatitis or other hepatitis, cirrhosis, fatty liver and hereditary liver diseases.
- •Previous use of anti-PD-1 antibody, anti-PD-l1 antibody, anti-PD-l2 antibody or anti-CTLA-4 antibody;
- •Patients with active tuberculosis (TB);
- •Received systemic immunosuppressive within 4 weeks prior to day 1 of the first cycle;
- •Pregnancy test positive;
- •Known human immunodeficiency virus (HIV) infection;
- •A history of severe allergy, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
- •Those who are known to be allergic to biological drugs produced by hamster ovary cells in China, or to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbate (components of the experimental drugs);
- •Patients who have previously received allogeneic stem cells or parenchymal organ transplantation.
研究组 & 干预措施
MSI-H advanced colorectal cancer
Experimental
干预措施: JS001 (Drug)
结局指标
主要结局
objective response rate
时间窗: 12 Weeks from the drug firstly being taken
The 12 week objective response will be measured according to RECIST v1.1
次要结局
未报告次要终点
研究者
Xu jianmin
Deputy director of the colorectal cancer center
Fudan University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Prospective Study of Immune Function and PD-1 Antibody Therapy Efficacy Predictors on CAEBV and EBV-HLH PatientsSecondary Hemophagocytic LymphohistiocytosisChronic Active Epstein-Barr Virus InfectionNCT05841342Beijing Friendship Hospital128
招募中
2 期
Anti-PD-1 Antibody Combined With Peg-Asparaginase and Chidamide for the Early Stage of NK/T Cell LymphomaImmune Checkpoint InhibitorChemotherapy EffectEpigenetic DisorderNK/T-cell Lymphoma of Nasal CavityNCT04414969Hunan Cancer Hospital35
Unknown
2 期
Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical CancerUterine Cervical NeoplasmsCervical NeoplasmsCervix CancerCervical CancerNCT04096911Buhai Wang20
已完成
1 期
Safety and Tolerability of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Patients With Advanced Breast CancerBreast CancerNCT02838823Shanghai Junshi Bioscience Co., Ltd.20
已完成
1 期
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast CancerBreast Neoplasm Malignant FemaleAdvanced Breast CancerNCT05812326Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University15