metastatic colorectal cancer
Conditions
Interventions
nal-IRI+5-FU/LV+ bevacizumab group:Irinotecan liposomes (II) combined with 5-FU/LV and bevacizumab
FOLFIRI+ Bevacizumab:Irinotecan in combination with 5-FU/LV and bevacizumab
Sponsors
Kunshan First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old and = 75 years old, gender not limited; 2. Diagnosed with colon or rectal cancer through histopathology and/or cytology, clinical records show advanced metastatic colon or rectal cancer that cannot be surgically removed (i.e., classified as stage IV according to the UICC/AJCC TNM staging system [8th edition, 2017]); 3. According to the RECIST v1.1 standard, there must be at least one measurable target lesion (i.e., non lymph node lesions with a CT scan length of = 10 mm and lymph node lesions with a CT scan length of = 15 mm); 4. Previously received first-line standard treatment with oxaliplatin ± VEGF/EGFR for metastatic diseases and treatment failure or intolerance; 5. ECOG (Eastern Cooperative Oncology Group) physical status score 0-1; 6. Expected survival time = 3 months; 7. There must be no major organ dysfunction, meaning that the organ function level and relevant laboratory indicators of the subjects within 14 days before randomization must meet the following requirements: (1) Blood routine (no supportive treatment such as blood transfusion, platelet transfusion, growth factor, etc. within 14 days before starting the study treatment): White blood cell (WBC) = 3.0 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelet count (PLT) = 100 × 109/L; Hemoglobin (Hb) = 90 g/L (2) Blood biochemistry: serum albumin (ALB) = 30 g/L; ALT/AST = 2.5 times the upper limit of normal (ULN), and ALT/AST = 5 times ULN if there is liver metastasis; Total bilirubin (TBIL) = 1.5 × ULN; Serum creatinine (Cr) = 1.5 × ULN, or endogenous creatinine clearance rate calculated according to Cockcroft Gault formula = 60 mL/min (3) Urine routine: Urine routine indicates urinary protein<++; If the baseline urinary protein is =++, it needs to be confirmed that the 24-hour urinary protein quantification is = 1.0g. (4) Coagulation function (within 14 days before starting study treatment): Prothrombin time (PT) or activated partial thromboplastin time (aPTT) = 1.5 × ULN, international normalized ratio (INR) = 1.5 × ULN (not receiving anticoagulant therapy); If the subject is treated with stable doses of anticoagulants or vitamin K antagonists (such as warfarin, heparin, or their analogues), and the international normalized ratio (INR) of prothrombin time is = 1.5, it is allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100mg) for preventive purposes; (5) Cardiac function: Normal 12 lead electrocardiogram or abnormal 12 lead electrocardiogram judged by researchers to have no clinical significance (i.e. male QTcF<450 ms, female QTcF<470 ms); Left ventricular ejection fraction (LVEF) = lower limit of normal (i.e. LVEF = 50%); 8. Other anti-tumor treatments received in the past must have ended treatment for 4 weeks or more, and the general physical condition or related adverse reactions have been restored (toxicity = grade 1) or reached a stable state; 9. Within 7 days before randomization, the serum pregnancy test of women of childbearing age must be negative and they must be non lactating; Female participants of childbearing age or male participants with partners of childbearing age must agree to use medically licensed contraceptive measures (such as intrauterine devices, male surgical sterilization, birth control pills, or condoms) during the trial period and within 6 months after the end of the study treatment period; 10. Voluntarily participate and sign an informed consent form; 1
Exclusion criteria
Exclusion criteria: 1. Have had malignant tumors other than colorectal cancer within the past 5 years prior to screening (excluding cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, and malignant tumors assessed by researchers as having low risk of metastasis and death); 2. It is known that the tumor tissue has been confirmed by immunohistochemistry to have mismatch repair deficiency (dMMR) status, or by second-generation sequencing (NGS)/polymerase chain reaction (PCR) methods to have microsatellite high instability (MSI-H) status, and has been evaluated by researchers to be suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors); 3. Second generation sequencing (NGS)/polymerase chain reaction (PCR) methods confirmed BRAF V600E mutation in patients with poor chemotherapy prognosis; 4. For patients with suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI) must be performed within 28 days before starting treatment to rule out central nervous system metastases; 5. Previously received chemotherapy based on irinotecan/irinotecan liposomes; 6. Use strong inhibitors/inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days before starting the drug study; 7. Participated in clinical trials of other drugs within 4 weeks prior to randomization; 8. Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; NCI-CTCAE v5.0>grade 2 inflammation; Diarrhea with NCI-CTCAE v5.0>grade 1); 9. There are serious complications, active infections or uncontrolled diabetes that hinder the treatment of the investigational drug: (1) Uncontrolled serious medical diseases that the researchers think will affect the ability of the subjects to receive the treatment of the research scheme, such as serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc; (2) Screening for arterial/venous thrombotic events that occurred within the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (excluding those caused by venous catheterization during previous chemotherapy and judged to have recovered by researchers), and pulmonary embolism; (3) Imaging shows that the tumor has invaded important blood vessels or the researchers have determined that the patient's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment; (4) The subject has active, known or suspected autoimmune diseases, including systemic lupus erythematosus, Hashimoto's thyroiditis, scleroderma, nodular polyarteritis or autoimmune hepatitis; Subjects suffering from type I diabetes, hypothyroidism only requiring hormone replacement, skin diseases not requiring systemic treatment (such as leukoplakia, psoriasis or alopecia), or diseases that are not expected to recur without external triggers are allowed to participate; (5) There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the year prior to medication should be excluded, even if they have already been treated; Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have received standardized anti tuberculosis treatment in the past; (6) Previous interstitial lung d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;progression free survival;Disease control rate;security; | — |
Countries
China
Contacts
Public ContactChen Minbin
Kunshan First People's Hospital
Outcome results
None listed