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New treatment option for Colorectal Cancer
Official title MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer
ClinicalTrials.gov ID: NCT06204484
What this study is testing
- What it's testing
- The aim of this clinical trial is to test whether minimal residual disease (MRD) status detected by circulating tumor DNA (ctDNA) could be used to guide precision therapy of post-surgery in colon cancer. The colon cancers are intended for resectable colon cancer of high-risk stage II and low-risk stage III status.
- 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 70
You may be able to join if
- Participants must fit all of the following to be enrolled in this study:
- Over 18 years old (including 18 years old) and under 70 years old (including 70 years old) when signing the informed consent form;
- The Eastern Cooperative Oncology Group (ECOG) physical status scores are 0-1 and do not deteriorate within 2 weeks before enrollment. The expected...
- Histological or cytological confirmed stage II high-risk and stage III low-risk none high microsatellite instability (MSI-H) colon adenocarcinoma...
- No evidence of distant metastasis (distant organ and/or distant lymph node metastasis) confirmed by comprehensive examination;
You likely can't join if
- Participants who meet any of the following criteria are not eligible for this study:
- Received any of the following treatments:
- Received neoadjuvant therapy in the past;
- Previously received any systemic chemotherapy or immunotherapy for colon cancer;
- Previously received any radiotherapy for colon cancer;
- Undergone colon cancer surgery in the past;
See the full eligibility criteria
Who can join
- Participants must fit all of the following to be enrolled in this study:
- Over 18 years old (including 18 years old) and under 70 years old (including 70 years old) when signing the informed consent form;
- The Eastern Cooperative Oncology Group (ECOG) physical status scores are 0-1 and do not deteriorate within 2 weeks before enrollment. The expected survival time is no less than 12 weeks;
- Histological or cytological confirmed stage II high-risk and stage III low-risk none high microsatellite instability (MSI-H) colon adenocarcinoma according to the Union for International Cancer Control/American Joint...
- No evidence of distant metastasis (distant organ and/or distant lymph node metastasis) confirmed by comprehensive examination;
- The distal end of the tumor is ≥12cm from the anal edge evaluated by pre-operative endoscopy. If the endoscopy is absent before surgery, the distance could be evaluated by radiology or during the surgery;
- Patients who have not received neoadjuvant therapy and can achieve R0 radical resection;
- Sufficient surgical fresh tissue samples for customized personalized MRD testing panels detected by whole exome sequencing (WES); available for preoperative blood, post-operative day (POD) 3-7 blood, and POD 21-30 blood...
- Females of the childbearing period should take appropriate contraceptive measures and should not breastfeed from the screening stage to 3 months post-treatment. Before starting treatment, a negative pregnancy test, or...
- Post-menopause, defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy.
- Women younger than 50 years who have been amenorrhea for 12 months or more after cessation of all exogenous hormone therapy and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within...
- Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except bilateral tubal ligation.
- Male participants should use barrier contraception (i.e., condoms) from the screening stage to 3 months post-treatment;
- The participants volunteer to join in the study and signed the informed consent in writing;
- Patients who are suitable for CAPEOX and mFOLFOXIRI adjuvant therapy.
What rules you out
- Participants who meet any of the following criteria are not eligible for this study:
- Received any of the following treatments:
- Received neoadjuvant therapy in the past;
- Previously received any systemic chemotherapy or immunotherapy for colon cancer;
- Previously received any radiotherapy for colon cancer;
- Undergone colon cancer surgery in the past;
- Previously or concomitantly diagnosed of other malignant tumors (except for adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer);
- Patients with other histological types rather than adenocarcinoma (such as neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.);
- MSI-H/deficient mismatch repair (dMMR) patients;
- Pathological, clinical, or radiologic evidence of metastatic lesions, including isolated, distant, or discontinuous intra-abdominal metastases;
- Patients with multiple primary colorectal cancer;
- Received other parts of open surgery rather than the colon within 14 days prior to the patient's enrollment;
- Cannot provide surgical tissues for customized personalized MRD testing or fail to customize personalized MRD testing panels.
- Cannot provide pre-operative blood, POD 3-7 blood, and POD 21-30 for MRD testing.
- Suffer from other serious diseases that may affect the follow-up and short-term survival according to the judgment of the investigators;
- Any other medical conditions and social/psychological problems, which make the patient unfit to participate in this study;
- History of blood transfusion within 2 weeks before surgery or during surgery;
- Those who cannot afford contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for clinical follow-up;
- Previously used Chinese patent medicine (CPM) with anti-tumor effect. Those who have used CPM with anti-tumor effect for less than 7 days, and have stopped for over 2 weeks can be enrolled in the study;
- Have serious or uncontrolled systemic diseases (such as severe mental disease, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal diseases, left...
- Fever and body temperature above 38°C within the past 1 week, or active infection with clinical significance. Active tuberculosis. Active fungal, bacterial, and/or viral infections requiring systemic treatment;
- Those with active bleeding or new thrombotic disease who are taking therapeutic anticoagulant drugs or have bleeding tendency;
- Those with severe clinical abnormalities in rhythm, conduction, or morphology on the resting electrocardiogram, such as complete left bundle branch block, second-degree cardiac block, clinically significant ventricular...
- Myocardial infarction, coronary/peripheral artery bypass, or cerebrovascular accident occurred within 3 months;
- QT interval (QTc) ≥450ms for males and ≥470ms for females in 12-lead electrocardiogram;
- Presence of risk factors leading to prolongation of the QTc or arrhythmia, such as heart failure, ≥CTCAE (version 4.03) 2nd-degree hypokalemia (2nd-degree hypokalemia is defined as serum potassium \< the lower limit...
- Intake of any drug known to prolong the QT interval within 2 weeks before enrollment;
- Insufficiency of bone marrow reserve or organ function, reaching any of the following laboratory limits (without corrective treatment within 1 week before blood draw for laboratory examination):
- Absolute neutrophil count \<1.5×109/L;
- Platelet count \<90×109/L;
- Hemoglobin \<90 g/L (\<9 g/dL);
- Alanine aminotransferase \>3 times the upper limit of normal (ULN);
- Aspartate aminotransferase\>3×ULN
- Total bilirubin \> 1.5×ULN;
- Creatinine \> 1.5×ULN or creatinine clearance rate \< 45 mL/min (calculated by Cockcroft-Gault formula);
- Serum albumin (ALB) \<28 g/L;
- Female people who are pregnant, lactating, or planning pregnancy during the study;
- Other circumstances in which the researchers assess that participants are not fit for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 70 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.