Colorectal cancer
Conditions
Interventions
group 1:Irinotecan Liposomal Injection (II) + 5-FU/LV± Bevacizumab/Cetuximab
group 2:Irinotecan injection + 5-FU/LV± bevacizumab/cetuximab
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age 18~75 (including 18 and 75 years old), male or female Patients with histopathologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum (classified as stage IV according to the UICC/AJCCTNM staging system (8th edition, 2017)) Patients in the unresectable metastatic stage who have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, molecularly targeted drug therapy, immunotherapy, biological therapy, and other investigational treatments, etc.) In patients with prior neoadjuvant or adjuvant therapy, the first detection of metastasis must be = 6 months apart from the date of the last dose of neoadjuvant or adjuvant therapy At least one measurable lesion must be available as a target lesion (the target lesion should not have received localized treatment such as radiotherapy, and lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to be occurring and meets RECIST 1.1 criteria) ECOG (Eastern Cooperative Oncology Group) physical status score: 0 to 1 Expected survival = 6 months; Major organ function is good, that is, the following criteria are met (in the case of no receipt of any blood components, cell growth factors within 14 days prior to enrollment): 1)Neutrophils = 1.5 x 109/L,2)Platelets= 100×109/L,3)Hemoglobin = 90 g/L,4)Serum albumin = 30 g/L,5)Total bilirubin = 1.5 x ULN (biliary obstruction allowing biliary drainage),6)AST and ALT = 3 x ULNN (= 5 x ULN if liver metastases,7)INR = 1.5 x ULN and APTT = 1.5 x ULN (screening enrollment is possible for patients on stable doses of anticoagulant therapy such as low molecular heparin or warfarin and whose INR is within the expected therapeutic range of anticoagulants),8)ECG: QTcF =450ms (male), =470ms (female),9)Cardiac ultrasound: LVEF (left ventricular ejection fraction) =50% Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 6 months after completion of treatment. For men, surgical sterilization or agreement to use an appropriate method of contraception for the duration of the study and for 3 months after completion of treatment Voluntarily participated in this study and signed an informed consent form Adherence was good and agreed to cooperate in receiving survival follow-up.
Exclusion criteria
Exclusion criteria: Patients known to be microsatellite highly unstable (MSI-H) or mismatch repair protein deficient (dMMR) and assessed by the investigator to be suitable for treatment with an immune checkpoint inhibitor; This exclusion criterion does not apply to persons with known CNS metastases and corresponding symptoms of intracranial hypertension, if there are intracranial metastases but the lesions have been stabilized in the furnace for more than 14 days with local treatment; Received regimen chemotherapy containing oxaliplatin within 6 months prior to enrollment; Severe gastrointestinal disturbances ((greater than grade 1 inflammation or diarrhea)); Third interstitial effusion (e.g., large pleural effusion) that cannot reach a stable state except for ascites (no intervention is required after drain removal) in the 2 weeks prior to enrollment; Patients with clinically symptomatic ascites who require puncture or drainage or who have received previous ascites drainage within the past 4 weeks (except for patients with only small and manageable amounts of ascites on imaging but no clinical symptoms); Known interstitial lung disease, except for interstitial changes shown on imaging only; Severe infections (CTCAE > grade 2) such as severe pneumonia requiring hospitalization, bacteremia, and complications of infection within 4 weeks prior to enrollment; signs and symptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to enrollment (except for prophylactic antibiotic use); Patients with uncontrolled cardiac clinical symptoms or disease such as (1) NYHA class 2 or higher heart failure, (2) unstable angina, (3) myocardial infarction within 6 months, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; Malignant tumor other than colorectal cancer within 5 years prior to enrollment; Contraindications to any of irinotecan, 5-FU, or calcium folinate exist; Known hypersensitivity to irinotecan, 5-FU, calcium folinate and any of the ingredients in the above products; Combined active hepatitis B (hepatitis B surface antigen positive and HBVDNA = 500 IU/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above upper limit of normal); Known Acquired Immune Deficiency Syndrome (AIDS) or HIV positive, active syphilis infection; Pregnant or lactating women; Any other conditions that, in the opinion of the investigator, may result in the subject's inability to complete this study or pose an appreciable risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration Of Response;safety endpoint;tolerance endpoint;Pharmacoeconomics; | — |
Countries
China
Contacts
Public ContactFeng Gao
Mianyang Central Hospital
Outcome results
None listed