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

February 26, 2025 updated by: Li Wenhua, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to explore the following key questions: 1) whether replacing ordinary irinotecan in VIC protocol with irinotecan liposomes can improve the safety and efficacy of BRAF V600E mutation in second-line treatment of metastatic colorectal cancer; 2) To provide a reference for identifying the dominant population for the benefit of irinotecan liposomes through the exploration of a range of biomarkers (including but not limited to ctDNA, immune microenvironmental indicators, tumor mutation load, lymphocyte subsets, cytokines, gut microbes, and others). Thus, it provides more treatment options for BRAF V600E mutations in patients with metastatic colorectal cancer

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irinotecan liposome gourp
Irinotecan liposomes combined with cetuximab + vermofenib
Drug: Irinotecan liposomes combined with cetuximab + vermofenib
Vermofenil 960mg orally twice daily; Irinotecan liposomes, 70mg/m2, d1, 90 min intravenously, Q2W; Cetuximab 500mg/m2, d1, Q2W;
Other Names:
  • Irinotecan liposomes+VC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: The evaluation period was up to 24 months from the date the participant entered the clinical study and started the medication
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
The time from the start of treatment to the first recording of PD or death, whichever occurs first
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
Time Frame: 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
The time between the start of treatment and the first recorded death
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
Time Frame: Incidence and severity of adverse events in treatment regimens up to 24 months
Incidence and severity of adverse events in treatment regimens
Incidence and severity of adverse events in treatment regimens up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Wenhua Li, Ph.D, Affiliated Cancer Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FudanU.2411307-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the research is completed, it is decided to share according to the research results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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