Colorectal Cancer
Conditions
Interventions
Case series:None
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; 2.Life expectancy is more than 3 months; 3.Has at least one measurable lesion other than the cranial brain; 4.Patients with unresectable or metastatic colorectal cancer with MSI-H or dMMR diagnosed by histopathological or cytological examination of the research center; 5.ECOG score 0-2 points; 6.No brain metastases, or associated with asymptomatic brain metastases, or symptomatic brain metastases that have been treated and stabilized.
Exclusion criteria
Exclusion criteria: 1.Patients with meningiomas or meningeal metastases or unstable brain metastases; 2.Cerebrovascular accident (excluding lacunar cerebral infarction, mild cerebral ischemia or transient ischemic attack), myocardial infarction, unstable angina pectoris, and poorly controlled arrhythmia (including QTc interval >=450 ms in males and >=470 in females) occurred within six months prior to the first administration of the study drug Ms) (QTc interval calculated by Fridericia formula); 3.According to the New York Heart Association (NYHA) standard grade III or IV cardiac insufficiency or color doppler echocardiography: left ventricular ejection fraction (LVEF) 10 mg/day prednisone or equivalent doses of similar drugs) or other immunosuppressive therapy within 14 days before the first dose of the study drug or during the study period. Enrollment is permitted, however: in the absence of active autoimmune disease, adrenal hormone replacement therapy with inhaled or topical steroids or a therapeutic dose of prednisone <=10 mg/day is permitted; 9.Received any T cell co-stimulation or immune checkpoint therapy in the past, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibition agents, PD-L1/2 inhibitors, or other drugs that target T cells; 10.Known history of severe hypersensitivity to any monoclonal antibody or study drug excipients; 11.Prior systemic antitumor therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression free survival;Overall survival;Disease Control Rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactHao Jing
Qilu Hospital of Shandong University
Outcome results
None listed