Colorectal cancer
Conditions
Interventions
Sponsors
Department of Oncology, Jiangjin Hospital affiliated to Chongqing University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joins the study and signs the informed consent; 2. Age: 18-80; 3. The patient was histologically confirmed as colorectal adenocarcinoma and MSS/pMMR was pathologically confirmed by biopsy; 4. Genetic test confirmed RAS gene mutation; 5. No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy; 6. mCRC with previous failure of first-line advanced chemotherapy, or advanced mCRC that cannot tolerate chemotherapy; 7. Activity status score: ECOG 0-2; 8. Life expectancy: more than 6 months; 9. The functions of vital organs meet the following requirements: Neutrophil absolute count (ANC) >= 1.5×109/L; Platelet >= 75×109/L;Hemoglobin >= 6g/dL; Serum albumin >= 2.8g/dL; ALT and AST= 50mL/min; 10. Fertile female subjects should perform a serum pregnancy test within 72 hours prior to the first dose, prove negative, and be willing to use an effective method of contraception during the trial period up to 3 months after the last dose. Male subjects whose partner is a woman of reproductive age should use an effective method of contraception during the trial period and for 3 months after the last dose. Examples include dual screen contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the woman has gone through natural menopause, artificial menopause or sterilization (e.g., hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. The presence or history of any active autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded); 2. Immunosuppressive, or systemic, or absorbable local hormone therapy is being used for immunosuppressive purposes (dose > 10mg/ day of prednisone or other equivalent hormone) and continued to use within 2 weeks prior to enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. subjects with clinically symptomatic and untreated active brain metastases or meningeal metastases; 5. Previous treatment with other PD-1 antibodies or other immunotherapy targeting PD-1/PD-L1; 6. have heart clinical symptoms or diseases that are not well controlled, such as :(1) nyha class 2 or more heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention; 7. have known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulopathy, thrombocytopenia, hyplenism, etc.) or are receiving thrombolytic or anticoagulant therapy; 8. Urine routine indicated urine protein >= ++, or confirmed 24-hour urine protein level >= 1.0g; 9. Had clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, active bleeding, fecal occultional blood ++ or above at baseline, or had vasculitis, etc. 10. Occurrence of arteriovenous/venous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., within 6 months before enrollment; 11. Subjects with active infection; 12. Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HEPATITIS B: HBsAg positive and HBV DNA>= 10^4 copy number/mL; Hepatitis C: HCV antibody positive); 13. Other intermediate and advanced malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and ovarian cancer); 14. Received live vaccine less than 4 weeks prior to study administration or possibly during study period; 15. A known or suspected allergy to the study drug or to any drug given in connection with the study; 16. In the investigator's judgment, the subject has other conditions that may affect the study results or cause the study to be stopped in the middle of the study, such as drug abuse, serious illness (including mental illness such as epileptic seizures), and other medical, psychological or social conditions that may endanger the patient's safety and compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;progression-free survival;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactDebing Xiang
Jiangjin Hospital affiliated to Chongqing University
Outcome results
None listed