NCT06763029 Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
| NCT ID | NCT06763029 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Colorectal Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2025-02-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
Wenhua Li, Ph.D
PRINCIPAL INVESTIGATOR
Affiliated Cancer Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06763029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06763029 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06763029 currently recruiting?
Yes, NCT06763029 is actively recruiting participants. Contact the research team at whliiris@hotmail.com for enrollment information.
Where is the NCT06763029 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06763029 clinical trial?
NCT06763029 is sponsored by Fudan University. The principal investigator is Wenhua Li, Ph.D at Affiliated Cancer Hospital of Fudan University. The trial plans to enroll 36 participants.
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