Colorectal Cancer MetastaticPhase 2VICPROIRINCT06763029
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
A Phase 2 study testing Irinotecan liposomes combined with cetuximab + vermofenib in people with Colorectal Cancer Metastatic, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Irinotecan liposomes combined with cetuximab + vermofenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jinjia Chang, PhD, 8621-18017317729, iamchangjinjia@163.com
About this study
Official title: 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.
Read the 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
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Irinotecan liposomes combined with cetuximab + vermofenib
- Keywords
- Colorectal cancer, Irinotecan liposomes, BRAF V600E mutation, Vermofenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposomes combined with cetuximab + vermofenibDrug
Also called Irinotecan liposomes+VC
Vermofenil 960mg orally twice daily; Irinotecan liposomes, 70mg/m2, d1, 90 min intravenously, Q2W; Cetuximab 500mg/m2, d1, Q2W;
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan liposome gourp | Experimental | Irinotecan liposomes combined with cetuximab + vermofenib Receives: Drug: Irinotecan liposomes combined with cetuximab + vermofenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 time from the start of treatment to the first recording of PD or death, whichever occurs first
Measured: 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 time between the start of treatment and the first recorded death
Measured: 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
Measured: Incidence and severity of adverse events in treatment regimens up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start26 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm, prospective study
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Wenhua, Fudan University
- Investigators
- Wenhua Li, Ph.D, Principal investigator, Affiliated Cancer Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763029
- Sponsor's protocol ID
- FudanU.2411307-18
- Acronym
- VICPROIRI
- Status last verified
- Feb 2025
- First submitted
- 2 Jan 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is completed, it is decided to share according to the research results
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Exploratory Study of Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced RAS Wild /BRAF Mutated Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06763029
- Acronym / sponsor ID
- VICPROIRI / FudanU.2411307-18
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Colorectal cancer, Irinotecan liposomes, BRAF V600E mutation, Vermofenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, prospective study
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome gourp | Experimental | Drug: Irinotecan liposomes combined with cetuximab + vermofenibIrinotecan liposomes combined with cetuximab + vermofenib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan liposomes combined with cetuximab + vermofenibAlso: Irinotecan liposomes+VCVermofenil 960mg orally twice daily; Irinotecan liposomes, 70mg/m2, d1, 90 min intravenously, Q2W; Cetuximab 500mg/m2, d1, Q2W; | Drug | Irinotecan liposome gourp |
Primary outcome
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
3 secondary outcomes
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
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
Adverse event
Time frame: Incidence and severity of adverse events in treatment regimens up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No. After the research is completed, it is decided to share according to the research results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenhua Li, Ph.D principal investigator
Affiliated Cancer Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan liposomes combined with cetuximab + vermofenib in people with Colorectal Cancer Metastatic, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhua Li, Ph.D (+86 18017317210, whliiris@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.