Colorectal cancer
Conditions
Interventions
Group A:Sequential therapy with arotinib, oxaliplatin, capecitabine, and paclitaxel
Group B:Simultaneous treatment with arotinib + oxaliplatin + capecitabine + paiampilizumab
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 and 75 years; 2. Patients with stage iv metastatic colorectal cancer (T1-4N0-2M1) diagnosed histopathologically as initially unresectable (excluding potentially resectable patients); 3. Patients who have not received prior systemic treatment, including chemotherapy, targeted and immunotherapy, or relapse more than 6 months after completion of adjuvant chemoradiotherapy/radical surgery; 4. Have at least one measurable lesion according to RECIST 1.1; Measurable lesions should not have received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy can also be selected as target lesions if they are confirmed to progress and meet RECIST 1.1 criteria); 5. The time from the end of palliative treatment for local lesions (non-target lesions) to the time of receiving treatment > 2 weeks; 6. ECOG PS score: 0-1; The expected survival is more than 3 months; 7. Have adequate organ and bone marrow functions, that is, meet the following criteria: (1) Blood routine examination standards shall meet: Monolingual hemoglobin (HB) >= 90 g/L (no transfusion within 28 days); Monolingual absolute neutrophil count (ANC) >= 1.5x10^9/L; Spontaneous platelet count (PLT) >= 100x10^9/L. (2) Biochemical tests shall meet the following standards: Anyway, serum total bilirubin (TBIL) = 60mL /min; (Cockcroft-Gault formula) (3) Full coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) <=1.5 TIMES ULN; 8. Women of childbearing age should take appropriate contraceptive measures and avoid breastfeeding for 3 months from screening to cessation of study treatment. A pregnancy test is negative or there is no risk of pregnancy if one of the following criteria is met prior to commencement of administration: A. Postmenopause was defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; B. Women younger than 50 years of age may also be considered postmenopausal if they have amenorrhea for 12 months or more after discontinuing all exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range; C. Has undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except bilateral tubal ligation. For men, consent is required to use an appropriate method of contraception or to have been surgically sterilized during the trial period and 8 weeks after the last administration of the trial drug; 9. Patients voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior systemic chemotherapy, targeted therapy, or immunotherapy, and any investigational drug within 30 days; 2.Received radiotherapy or surgery within 30 days, except for biopsy; 3. Received any vaccine treatment within 30 days prior to enrollment (including anti-infective vaccine, such as influenza vaccine, varicella vaccine, etc.); 4. Patients with active bleeding within 2 months of the primary lesion; 5. Have a history of any active autoimmune disease or autoimmune disease or suspected autoimmune disease, including BEING HIV positive, and have a history of preparing or prior organ transplantation; Including HIV positive or other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 6. Subjects with neurological symptoms who are known to have brain metastases and/or meningeal metastases should undergo CT/MRI to exclude brain metastases; 7. Patients with any severe and/or uncontrolled disease, including: (1) Looney spends time (within 5 years) or simultaneously having an uncured malignant tumour. Except for localized tumors that have been cured; (2) Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5ULN), having a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; Long-term antiplatelet therapy is required (aspirin >=300mg/ day, clopidogrel >=75mg/day) Note: The use of low-dose heparin (60, 000 to 12, 000 U per day for adults) or low-dose aspirin (100 mg or less per day) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) = 450ms in men and >= 470ms in women) (QTc interval calculated using Fridericia formula); According to NYHA standard (3) Grade II or above cardiac dysfunction or color doppler echocardiography: LVEF (left ventricular ejection fraction) = 150 mmHg or diastolic blood pressure >= 100 mmHg); Acute myocardial infarction, malignant arrhythmias (including QT interval >= 440 ms) and grade ? cardiac insufficiency; (6) Active or uncontrolled severe infection, with unexplained fever (body temperature >38.5 ° C) occurring just before the first dose (7) Promoting liver diseases such as cirrhosis, decompensated liver disease and chronic active hepatitis; (8) Oxidative diabetes was poorly controlled (fasting blood glucose (FBG) > 10 mmol/L); (9) Isotonic urine routine suggested urinary protein >= ++, and confirmed 24-hour urinary protein level > 1.0g; 8. Patients with known hereditary or acquired bleeding and thrombotic tendency, who have experienced arteriovenous or venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 9. Patients with bleeding tendencies (such as active gastrointestinal ulcer) or who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogues; 10. Known to be allergic to the test drug; 11. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 12. Pregnant or lactating women; 13. C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression free survival, PFS; | — |
Countries
China
Contacts
Public ContactJie Ma
Outcome results
None listed