colorectal cancer
Conditions
Interventions
single arm:camrelizumab, bevacizumab and DC-CIK
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 years old and above, both male and female; 2. Patients diagnosed with colorectal cancer by histopathology or cytology; 3. Patients who had previously received 1 systemic chemotherapy regimen for colorectal cancer that was ineffective or advanced, or had disease progression or recurrence within 6 months after receiving adjuvant chemotherapy, or were unable to tolerate or unwilling to undergo chemotherapy; had not used of immunocheckpoint inhibitors or bevacizumab or dc-cik previously; 4. ECOG performance status 0-1; 5. Life expectancy >=12 weeks; 6. There were measurable lesions that met the RECIST 1.1 criteria; 7. The main organs functioned normally, and there were no serious abnormalities of heart, liver and kidney. The laboratory tests met the following requirements: ALT AST 50ml/min(Cockcroft-Gault) Normal urine routine or urine protein < (++), or 24-hour urine protein < 1.0g. 8. Coagulation function is normal, no active bleeding and thrombotic diseases: a.INR <= 1.5 x ULN; b.APTT <= 1.5 x ULN; c.PT <= 1.5 x ULN. 9. Women of child-bearing age are required to have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and to voluntarily use the appropriate method of contraception during the observation period and within 12 weeks after the last administration of the study drug;In the case of men, use of appropriate methods of contraception during the period of observation and within 12 weeks of the last administration of the study drug should be approved for surgical sterilization or consent; 10. The patient voluntarily joined the study and signed the informed consent (ICF). 11. It is expected that patients with compliance will be able to follow up the efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Other malignancies were diagnosed 5 years before the first use of the study drug; 2. Known allergy to camrelizumab, bevacizumab, dc-cik or pharmaceutical excipients;Or had a severe allergic reaction to other monoclonal antibodies; 3. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement Can be included after treatment)); patients with childhood asthma who have completely remissioned and no intervention or vitiligo can be included after adulthood, and patients who require medical intervention with bronchodilators cannot be included; 4. People with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (hepatitis C antibody positive, and high HCV-RNA Depending on the detection limit of the analytical method) or co-infection with hepatitis B and C; 5. Used immunosuppressive drugs within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie, no more than 10 mg / day of prednisolone or equivalent drug physiology Dose of other corticosteroids); 6. Within 4 weeks before the first dose or plan to receive live attenuated vaccine during the study period; 7. Severe infections (e.g. antibiotics, antifungal or antiviral drugs required intravenous drip) within 4 weeks before the first medication, or unexplained fever> 38.5 degrees C during screening / prior to the first dose; 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Lung diseases related to immunity; 10. Suffering from hypertension, the antihypertensive drug treatment still can not reduce to the second level of hypertension (systolic blood pressure II); unstable or severe angina; acute myocardial infarction occurred within 6 months; clinically significant Patients with supraventricular or ventricular arrhythmias requiring clinical intervention; left ventricular ejection fraction (LVEF) 30 ml), hemoptysis (bleeding within 4 weeks > 5 ml) and thromboembolic events (including stroke events and / or transient) within 12 months Ischemic attack); 13. Participate in other clinical trials or participate in clinical studies of any other drugs within 4 weeks, or no more than 5 half-lives from the last study; 14. Other circumstances that the investigator considers unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactDalu Kong
Tianjin Cancer Hospital
Outcome results
None listed