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Recruiting Phase 2

Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

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About this study

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.

Condition
Colorectal Cancer Metastatic
Tested
Irinotecan liposomes combined with cetuximab + vermofenib
Sponsor
Fudan University

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Colorectal Cancer Metastatic
  • 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 7

  • 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.

Where

1 site, 1 recruiting

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.