To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.
Age ≥ 18 years old and ≤ 75 years old, gender is not limited;
Diagnosis of colorectal cancer by histopathology and/or cytology, clinical Records showing inoperable advanced metastatic colon or rectal cancer (ie, stage IV according to the UICC AJCC TNM staging system [8th edition 2017]) ;
At least 1 measurable target lesion according to RECIST v1.1 criteria (ie, non-nodal lesions with a CT scan length ≥10 mm and nodal lesions with a CT scan short diameter ≥15 mm) ;
Prior first- or second-line oxaliplatin-based therapy with treatment failure or intolerance*; Note: *Treatment failure or intolerance is defined as (1) disease progression during treatment or disease progression within 6 months of final treatment, both with clear evidence of imaging or clinical progression, and (2) patients who withdrew from treatment because of intolerance of an adverse event of the treatment, as per NCI-CTCAE v5.0 criteria, intolerance is defined as: a. Hematological toxicity: grade III neutropenia accompanied by fever >38.5°C, grade III thrombocytopenia with bleeding symptoms, and other grade IV or higher hematologic toxic reactions; b. Non-hematological toxicity: grade III or higher non-hematological toxic reactions; and c. Achievement of the above toxic reactions, which in the judgment of the investigator make continuation of the original regimen of Treatment.
Have had a malignant tumor other than colorectal cancer within 5 years before the screening (cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, and malignant tumors assessed by researchers as having a low risk of metastasis and death except);
Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry, or a microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase chain reaction (PCR) methods, they were evaluated by the investigators as being suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors)
The second generation sequencing (NGS)/polymerase chain reaction (PCR) method confirmed that it is a BRAF V600E mutation, which is unfavorable for patients with chemotherapy prognosis;
For those who are known to have central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced nuclear magnetic resonance (MRI) must be performed within 28 days before the first medication to rule out central nervous system metastases;