BridgeMD
New treatment option for ctDNA
Official title A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer
ClinicalTrials.gov ID: NCT07562490
What this study is testing
What is FOLFOX?
FOLFOX is an investigational medicine, being studied as a potential treatment for ctdna.
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
- Patients with T4N+ or T1-3N2 disease will be randomly assigned to either the control group (FOLFOX/CAPOX for 6 months) or the intervention group (FOLFOX/CAPOX plus bevacizumab for 6 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
- 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
- Age ≥18 years, regardless of sex;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months;
- Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;
- Positive ctDNA status at 1 month after surgery;
- Expected survival of \>12 months;
You likely can't join if
- Receipt of neoadjuvant therapy prior to surgery;
- Blood transfusion during surgery or within 2 weeks prior to surgery;
- Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;
- Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric...
- Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment...
See the full eligibility criteria
- Age ≥18 years, regardless of sex;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months;
- Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;
- Positive ctDNA status at 1 month after surgery;
- Expected survival of \>12 months;
- Ability to understand and willingness to sign a written informed consent form (personally or via a legally authorized representative/guardian), indicating that the subject understands the study objectives and required...
- Receipt of neoadjuvant therapy prior to surgery;
- Blood transfusion during surgery or within 2 weeks prior to surgery;
- Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;
- Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms;
- Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment, including myocardial infarction, congestive heart failure, unstable angina...
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
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.