metastatic colorectal cancer
Conditions
Interventions
Experimental group:Toripalimab in combination with chemotherapy and targeted therapy
Sponsors
Ethics CommitceOf Chinese PLA General Hosptial
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age= 18 years; (2) Colorectal cancer with liver metastasis or colorectal cancer with lung metastasis confirmed by pathology or imaging; (3) at least one measurable lesion according to criteria RECIST1.1; (4) Patients who can undergo surgery after preoperative evaluation; (5) have not received any systemic treatment for colorectal cancer prior to enrollment in the study; (6) Adequate organ function: (1) Blood routine: no blood transfusion or colony-stimulating factor therapy within 14 days: neutrophil count = 1.5×109Platelet count = 75×109/L;Hemoglobin=80 g/L; (2) Liver function: serum total bilirubin =2 times the upper limit of normal, alanine aminotransferase and aspartic acid aminotransferase = 5.0 times ULN, alkaline phospholipase = 2.5 times ULN, albumin > 30 g/L; (3) Renal function: creatinine =1.5 times ULN; creatinine clearance = 50 mL/min (calculated according to CockcroftGault formula); (4) Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time = 1.5 times ULN. If participants are taking warfarin or heparin for anticoagulation, it is necessary to determine whether the drug is discontinued or not used to meet the requirements of the program; (5) Cardiovascular function: cardiac color ultrasound examination: left ventricular ejection fraction =50%; (7) ECOG PS score of 0-1; (8) Females and males of childbearing potential must agree to be given the consent form after signing the informed consent, during the study, and for 6 months after the end of the trial. Strict and effective contraceptive measures are taken, during which sperm donation is prohibited for men and women of childbearing age the pregnancy test result of the test subject must be negative during the screening period and within 24 hours before dosing; (9) Voluntarily join this study and sign the informed consent form
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hepatic encephalopathy in the past; (2) Severe pulmonary insufficiency (FEV1/FVC<50% or FEV1<50% predicted or maximum ventilation per minute (maximum volume per minute (MVV) <50 L/min), significant chronic obstructive pulmonary disease, or Patients with interstitial pneumonia; (3) Hypothyroidism with active, known or suspected autoimmune disease and only hormone replacement therapy can be selected Patients with degenerate, skin conditions (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment; (4) Patients who have received a live vaccine within 30 days prior to enrollment; (5) Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, and unstable heart disease within 6 months colic, stroke, or transient ischemic attack; or other patients who cannot tolerate surgery; (6) Received any investigational drug within 4 weeks prior to the first administration of study drug; (7) There is uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage (8) Have cardiovascular diseases that are not well controlled, including but not limited to:1) NYHA level II or above cardiac insufficiency; 2) history of unstable angina; 3) New heart attack in the last 3 months Colic, myocardial infarction within the last 6 months; 4) Clinically significant supraventricular or ventricular arrhythmias have not been presented Poor control after clinical intervention or intervention; 5) Hypertension that cannot be effectively controlled; (9) Active hepatitis B or C, chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and Patients with a viral load of less than 500 IU/mL may participate in the study, but will need to continue or start full for the duration of the study Standardized antiviral therapy for the course of treatment; (10) Positive for human immunodeficiency virus (HIV) antibody, or other acquired and congenital immunodeficiency Disease, or the presence of active tuberculosis infection, or the presence of active hepatitis (hepatitis B: if HBsAg or HBcAb positive, HBV-DNA =2000IU/ml for enrollment; Hepatitis C: HCV if hepatitis C antibody positive RNA negative may be enrolled), or active syphilis infection; (11) Patients who have undergone organ transplantation, including allogeneic bone marrow transplantation; (12) Those who are allergic to the study drug or its active ingredients and excipients; (13) Patients who cannot tolerate surgery; (14) Patients who are unable to swallow liquid food or who are unable to take oral medications as assessed by the investigator; (15) Pregnant and lactating females, or those of childbearing age who cannot guarantee effective contraception; (16) Those who are known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse, or who cannot cooperate with treatment for other reasons; (17) In the opinion of the investigator, the patient is not suitable to participate in this trial for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological remission rate;Overall survival, OS;Disease-free survival, DFS;R0 resection rate;Activity of Daily Living,ADL; | — |
Countries
China
Contacts
Public ContactChao Wu
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed