A single-arm, open-label clinical study of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer, aiming to evaluate the efficacy and safety of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer The medication regimen is irinotecan liposome (II) + capecitabine + bevacizumab + camrelizumab until disease progression or intolerable toxicity.
Patients pathologically diagnosed with colorectal cancer;
Received systemic treatment on the first line;
Age: 18 to 75 years old, gender not limited.
There must be at least one measurable lesion as the target lesion (in accordance with the RECIST v1.1 standard);
Patients with wild-type RAS and BRAF, whose primary lesion is located in the left colorectal tract, but who have not received cetuximab as the first-line treatment
Patients with advanced colorectal cancer who have MSI-H or dMMR
Those with a history of other malignant diseases in the last five years, except for cured skin cancer and cervical carcinoma in situ
For patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, the researcher will determine that the clinical severity may prevent them from signing the informed consent form or affect their compliance with oral medication
Single group
Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab
DrugZeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks. Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks
Progression-free survival (PFS）
Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any cause.
Objective response rate (ORR)
The objective response rate (ORR) is a key endpoint used in clinical trials, particularly in oncology, to assess the effectiveness of a treatment in shrinking or eliminating tumors. It is defined as the proportion of patients in a study who achieve a partial response (PR) or a complete response (CR) to the treatment.
Duration of remission (DoR）
Duration of remission (DoR) is a critical metric in clinical oncology and hematology, particularly when evaluating the effectiveness of treatments for cancers or other diseases that can enter a state of remission. It refers to the length of time during which a patient's disease remains in remission following treatment.
Disease Control Rate (DCR）
the proportion of patients whose disease is controlled by the treatment. It includes patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) after treatment.
Overall survival
OS is defined as the duration from the start of treatment or diagnosis until death from any cause. It represents the ultimate measure of a treatment's impact on patient longevity.
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