NCT06763029RecruitingPhase 2
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of 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
Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 26 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT06763029
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 26 Feb 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received BRAF inhibitors or irinotecan liposomes;
Other illness
- Proven allergic to the test drug and/or its excipients;
- 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;
Age
- Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures;
Other
- symptomatic, untreated brain metastases or meningeal metastases that fail to achieve clinical stability;
- Patients considered by the investigator to be unsuitable for this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.