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New treatment option for Colorectal Carcinoma
Official title Irinotecan Hydrochloride Liposome Injection (Ⅱ) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT06603376
What this study is testing
What is FOLFIRI + Vemurafenib + Cetuximab?
FOLFIRI + Vemurafenib + Cetuximab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for colorectal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Based on the upstream signaling features of BRAFV600E and the bypass feedback mechanisms, considering the pro-apoptotic effects of chemotherapy and the synergistic effects of targeted therapy, previous IMPROVEMENT trial creatively explored a balanced chemotherapy-targeted combination approach (FOLFIRI + Vemurafenib + Cetuximab) in advanced colorectal cancer patients with BRAF V600E mutaiton using a signle-arm study design, demonstrating significant therapeutic efficacy in these patietns . To further validate the effectiveness and safety of this regimen and to solidify its clinical value, it is crucial to conduct a randomized, controlled trial.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology.
- Patients with BRAFV600E mutation confirmed by tissue or blood testing.
- Patients who have not received systemic therapy or who have experienced metastasis or recurrence 12 months after completing adjuvant therapy.
- Patients must have at least one measurable lesion according to RECIST 1.1 criteria.
- Patients who received local radiotherapy at least 3 weeks before the first drug treatment are allowed to enroll, but lesions evaluated by RECIST...
You likely can't join if
- Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug.
- Patients with hypersensitivity to any component of the study regimen.
- Patients who are planning to conceive or are already pregnant.
- Patients with brain metastases who cannot accurately describe their condition.
- Patients with the following conditions within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina...
- Abnormal laboratory test results:
See the full eligibility criteria
- Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology.
- Patients with BRAFV600E mutation confirmed by tissue or blood testing.
- Patients who have not received systemic therapy or who have experienced metastasis or recurrence 12 months after completing adjuvant therapy.
- Patients must have at least one measurable lesion according to RECIST 1.1 criteria.
- Patients who received local radiotherapy at least 3 weeks before the first drug treatment are allowed to enroll, but lesions evaluated by RECIST should not be within the radiation field.
- Patients aged ≥18 years and ≤80 years.
- ECOG performance status of 0-2.
- Expected survival of ≥12 weeks.
- Patients must have the ability to understand and voluntarily sign a written informed consent.
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to the start of treatment. During the study, both the patient and their partner must use contraception.
- Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug.
- Patients with hypersensitivity to any component of the study regimen.
- Patients who are planning to conceive or are already pregnant.
- Patients with brain metastases who cannot accurately describe their condition.
- Patients with the following conditions within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina, congestive heart failure greater than NYHA Class 2, uncontrolled...
- Abnormal laboratory test results:
- Absolute neutrophil count (ANC) \<1,500/mm³;
- Platelet count \<75,000/mm³;
- Total bilirubin \>1.5 times the upper limit of normal (ULN); ALT (alanine aminotransferase) and AST (aspartate aminotransferase) \>2.5 times ULN (for patients with liver metastasis \>5 times ULN); Creatinine \>1.5 times...
- Patients who have had any cancer other than advanced colorectal cancer within five years prior to the start of the study treatment. Exceptions include cervical carcinoma in situ, cured basal cell carcinoma, and bladder...
- Patients with a history of drug abuse, substance abuse, or alcohol dependence.
- Patients who are legally incapacitated or have limited civil capacity.
- Any other conditions deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.