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

NCT06763029 | Recruiting Phase 2

• 1 other identifier: FudanU.2411307-18
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Keywords

Colorectal cancer; Irinotecan liposomes; BRAF V600E mutation; Vermofenib

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The proportion of patients with optimal tumor response, complete response (CR) or partial response (PR) assessed based on the RECIST v1.1 criteria

  The evaluation period was up to 24 months from the date the participant entered the clinical study and started the medication

Secondary Outcomes (3)

• Progression free survival

  The evaluation period was up to 24 months from the date of the subject's first medication to the date of first recorded progress or the date of death from any cause, whichever came first

• Overall survival

  The evaluation period was up to 24 months from the date of the subject's first medication to the date of death from any cause

• Adverse event

  Incidence and severity of adverse events in treatment regimens up to 24 months

Study Arms (1)

Irinotecan liposome gourp

EXPERIMENTAL

Irinotecan liposomes combined with cetuximab + vermofenib

Drug: Irinotecan liposomes combined with cetuximab + vermofenib

Interventions

Irinotecan liposomes combined with cetuximab + vermofenib DRUG

Vermofenil 960mg orally twice daily; Irinotecan liposomes, 70mg/m2, d1, 90 min intravenously, Q2W; Cetuximab 500mg/m2, d1, Q2W;

Also known as: Irinotecan liposomes+VC

Irinotecan liposome gourp

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wenhua Li, Ph.D

  Affiliated Cancer Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhua Li, Ph.D

CONTACT

+86 18017317210; whliiris@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine oncology

Model Details: Single-center, single-arm, prospective study

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)