Efficacy and safety of irinotecan liposomes combined with cetuximab + vermofenib in first-line failure of advanced RAS wild /BRAF mutated colorectal cancer, Exploratory analysis of biomarkers (including but not limited to ctDNA, immune microenvironment indicators, tumor mutation load, lymphocyte subsets, cytokines, gut microbes, and others) in relation to efficacy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* at least 18 years of age;
* Colorectal adenocarcinoma was confirmed by histological or cytopathological examination, and RAS wild /BRAF V600E mutation was detected by PCR or NGS;
* Failure or intolerance of standard first-line treatment. First-line regimens including oxaliplatin and/or irinotecan in combination with fluorouracil in patients with MSS; For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required;
* At least one measurable lesion according to RECIST v1.1;
* ECOG score is 0\~2;
* Good bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; Total bilirubin ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 ml/min (calculated according to Cockroft-Gault);
* Expected survival ≥3 months;
* Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this study and sign informed consent.
Exclusion Criteria:
* Patients who have previously received BRAF inhibitors or irinotecan liposomes;
* Proven allergic to the test drug and/or its excipients;
* symptomatic, untreated brain metastases or meningeal metastases that fail to achieve clinical stability;
* Acute or subacute intestinal obstruction or chronic inflammatory bowel disease;
* have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer;
* Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures;
* Patients considered by the investigator to be unsuitable for this study.
Primary outcome measure(s)
Objective response rate — The evaluation period was up to 24 months from the date the participant entered the clinical study and started the medication The proportion of patients with optimal tumor response, complete response (CR) or partial response (PR) assessed based on the RECIST v1.1 criteria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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