Colorectal cancer
Conditions
Interventions
Experimental group:Irinotecan liposome (II) combined with capecitabine and bevacizumab
Sponsors
Heze Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age > = 18 years old and =10 mm, short diameter of lymph node lesion on CT scan >=15 mm; 4. Previously received first-line standard treatment of oxaliplatin ±VEGF/EGFR for metastatic diseases and failed the treatment; 5. ECOG Physical Condition score: 0-1; 6. Expected survival time > = 3 months; 7. Immunohistochemistry: pMMR or MSI-L, MSS 8. Good function of vital organs means that the organ function levels and related laboratory indicators of the subjects within 14 days before the start of the study and treatment must meet the following requirements: (1) Blood routine (no blood transfusion, platelet transfusion, growth factor or other supportive treatments have been received within 14 days before the start of the study and treatment), White blood cell (WBC) > = 3.0×10^9/L; Absolute neutrophil count (ANC) > = 1.5×10^9/L; Platelet count (PLT) > = 100×10^9/L; Hemoglobin (Hb) > = 90 g/L (2) Blood biochemistry: Serum albumin (ALB) > = 30 g/L; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) = 60 mL/min. (3) Routine urine test: Routine urine test indicates urine protein = ++, it needs to be confirmed that the 24-hour urine protein quantification is = the lower limit of the normal value (that is, LVEF > = 50%); 9. Other anti-tumor treatments received previously should have been completed for 4 weeks or more, and the general physical condition or related adverse reactions have recovered (toxic reactions < = grade 1) or reached a stable state. 10. The serum pregnancy test of women of childbearing age must be negative within 7 days before the start of the study treatment, and they must be in the non-lactation period. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age must agree to take medically permitted contraceptive me
Exclusion criteria
Exclusion criteria: 1. Have had malignant tumors other than colorectal cancer within 5 years before screening (excluding cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and malignant tumors assessed by the investigator as having a low risk of metastasis and death); 2. For those with known central nervous system metastases, for patients clinically suspected of having central nervous system metastases, enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI) examinations must be conducted within 28 days before the start of the study and treatment to rule out central nervous system metastases. 3. Have previously received chemotherapy based on irinotecan/irinotecan liposomes or capecitabine; 4. Use of strong suppressor/inducer CYP3A4, CYP2C8 and UGT1A1 within 14 days before the start of the study treatment; 5. Participated in clinical trials of other drugs within 4 weeks before starting the research treatment; 6. Clinical records show severe gastrointestinal dysfunction (including bleeding and obstruction); Inflammation with NCI-CTCAE v5.0 > grade 2; Diarrhea with NCI-CTCAE v5.0 > 1 grade, or other conditions that the researcher determines may affect the intake, transport or absorption of the drug (including inability to swallow; After small intestinal resection or total gastrectomy, etc. 7. Pleural effusion or ascites requiring clinical intervention (NCI-CTCAE v5.0>= grade 2); 8. There are severe comorbidities, active infections or uncontrolled diabetes that hinder the treatment of the investigational drug: (1) Uncontrolled serious medical diseases that the researchers believe will affect the subjects' ability to receive treatment under the study protocol, such as combined severe internal diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc. (2) Hyperarterial/venous thrombosis events that occurred within one year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization due to previous chemotherapy and determined to have been cured by the researcher), and pulmonary embolism, etc. (3) Situations where imaging shows that the tumor has invaded the area around important blood vessels or where the researcher determines that the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage; (4) A previous history of interstitial lung disease, or (non-infectious) pneumonia requiring oral or intravenous steroid hormones; (5) There are poorly controlled clinical symptoms or diseases of the heart, such as: New York Heart Association (NYHA) grade 2 or above heart failure; Unstable angina pectoris Myocardial infarction occurred within 6 months; Supraventricular or ventricular arrhythmias with clinical significance that require treatment or intervention; (6) Positive for hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies; 9. Severe infections (NCI-CTCAE v5.0 > 2 grade) occurred within 4 weeks before screening, such as severe pneumonia, bacteremia, infectious complications, etc. that require hospitalization; If there are symptoms and signs of infection within 2 weeks before the start of the study treatment, intravenous antibiotic treatment is required (except for the case of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Security; | — |
Countries
China
Contacts
Public ContactWenxia Zhang
Heze Municipal Hospital
Outcome results
None listed