Combining irinotecan liposomes with cetuximab and vermofenib for advanced colorectal cancer

Phase II Exploratory Study of Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced RAS Wild /BRAF Mutated Colorectal Cancer

This study is testing if a new combination of treatments can help patients with advanced colorectal cancer, who haven't responded to previous therapies, feel better and have better outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: immunotherapy, cetuximab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06763029 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of irinotecan liposomes when combined with cetuximab and vermofenib in patients with advanced colorectal cancer who have failed first-line treatment. It focuses on patients with RAS wild/BRAF V600E mutations and aims to determine if this combination can improve treatment outcomes compared to standard irinotecan. Additionally, the study will explore various biomarkers to identify which patients may benefit most from this treatment approach. The research is designed to provide more options for patients with this specific mutation in metastatic colorectal cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed colorectal adenocarcinoma and RAS wild/BRAF V600E mutations who have failed or are intolerant to standard first-line treatments.

Not a fit: Patients with colorectal cancer who do not have the BRAF V600E mutation or those who have not failed first-line treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced colorectal cancer who have limited treatment choices after first-line failure.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches targeting BRAF mutations in colorectal cancer have shown promise in other studies.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Wenhua Li, Ph.D — Affiliated Cancer Hospital of Fudan University
• Study coordinator: Wenhua Li, Ph.D

Conditions: Colorectal Cancer Metastatic, Colorectal cancer, Irinotecan liposomes, BRAF V600E mutation, Vermofenib