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New treatment option for Colorectal Cancer
Official title Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
ClinicalTrials.gov ID: NCT05797077
What this study is testing
What is FOLFOX chemotherapy regimen?
FOLFOX chemotherapy regimen is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Also referred to as CapeOx chemotherapy regimen.
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
- The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.
- Phase 3: a large, late-stage study
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 75
You may be able to join if
- Both males and females, aged 18-75 years;
- Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have...
- Postoperative ctDNA-positive patients;
- ASA grade \< IV and/or ECOG performance status score ≤ 2;
- Participants must have a full understanding of the study and voluntarily sign an informed consent form.
You likely can't join if
- Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
- Patients with a history of other malignant tumors.
- Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate...
- Patients who are allergic to any component of the study.
- Patients who have received other tumor-related investigational drug treatments.
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
See the full eligibility criteria
- Both males and females, aged 18-75 years;
- Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);
- Postoperative ctDNA-positive patients;
- ASA grade \< IV and/or ECOG performance status score ≤ 2;
- Participants must have a full understanding of the study and voluntarily sign an informed consent form.
- Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
- Patients with a history of other malignant tumors.
- Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
- Patients who are allergic to any component of the study.
- Patients who have received other tumor-related investigational drug treatments.
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
- Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental...
- Patients with a history of severe mental illness.
- Pregnant or lactating women.
- Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.