Blood test may guide chemo decisions for colorectal cancer patients
NCT ID NCT07562711
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for people with high-risk stage II colorectal cancer who have a positive blood test for tumor DNA one month after surgery. It tests whether using that blood test to choose stronger or different chemotherapy can help clear the tumor DNA and prevent the cancer from coming back. About 340 participants will be randomly assigned to standard chemo or a personalized plan based on their blood test results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Capecitabine, FOLFOX, CAPOX, FOLFIRI
- What this could lead to
- If successful, this could show that using a blood test to personalize chemotherapy after surgery reduces the chance of cancer returning in high-risk stage II colorectal cancer patients.
- What could go wrong
- This is a Phase 2 trial with 340 participants, so results are still early. The approach may not improve survival or could lead to unnecessary side effects from stronger chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years, regardless of sex; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months; 3. Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer; 4. Positive ctDNA status at 1 month after surgery; 5. Expected survival of \>12 months; 6. 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 procedures and agrees to participate. Exclusion Criteria: 1. Receipt of neoadjuvant therapy prior to surgery; 2. Blood transfusion during surgery or within 2 weeks prior to surgery; 3. Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception; 4. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer; 5. Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms; 6. 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, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; Clearly diagnosed neurological or psychiatric disorders, including dementia or seizure disorders;Severe or uncontrolled infections;Active disseminated intravascular coagulation (DIC) or significant bleeding tendency;Significant impairment of major organ function; 7. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, China
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