ctDNAPhase 2CLEAR-01NCT07562659
Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer
A Phase 2 study testing Capecitabine in people with ctDNA and Colorectal Cancer (CRC), run by Fudan University at 1 site in China.
Trial summary
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ctDNA, Colorectal Cancer (CRC), Adjuvant Chemotherapy
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following 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 procedures and agrees to participate.
Who cannot join
- 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, 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; Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Guoxiang Cai
About this study
Official title: A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.
- Conditions
- ctDNA, Colorectal Cancer (CRC), Adjuvant Chemotherapy
- Being tested
- Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Patients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up Group | No intervention | In the follow-up group, patients with stage I and low-risk stage II CRC will not receive adjuvant therapy after surgery and will undergo ctDNA assessments at 3 and 6 months postoperatively. |
| Single-agent chemotherapy group | Experimental | Patients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's 2-year Progression-Free Survival
Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria.
Measured: Two-year Progression-Free Survival
Secondary outcomes (1)
ctDNA-clearance Rate
ctDNA clearance rate is defined as the proportion of patients with detectable circulating tumor DNA (ctDNA) at baseline who achieve conversion to undetectable ctDNA at a predefined post-treatment time point, as assessed by the specified ctDNA assay.
Measured: 3 month and 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ctDNAStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562659
- Sponsor's protocol ID
- 2410-Exp100
- Other IDs
- U25A20115
- Acronym
- CLEAR-01
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT07562659
- Acronym / sponsor ID
- CLEAR-01 / 2410-Exp100
- Conditions
- ctDNA, Colorectal Cancer (CRC), Adjuvant Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up Group | No intervention | –In the follow-up group, patients with stage I and low-risk stage II CRC will not receive adjuvant therapy after surgery and will undergo ctDNA assessments at 3 and 6 months postoperatively. |
| Single-agent chemotherapy group | Experimental | Drug: CapecitabinePatients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabinePatients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA. | Drug | Single-agent chemotherapy group |
Primary outcome
Patient's 2-year Progression-Free Survival
Time frame: Two-year Progression-Free Survival
Two-year Progression-Free Survival (PFS) is defined as the proportion of patients who remain alive without evidence of disease progression or recurrence within 24 months from the date of surgery (or randomization, as specified in the protocol). Disease progression is determined according to radiologic, clinical, or pathological criteria.
1 secondary outcome
ctDNA-clearance Rate
Time frame: 3 month and 6 month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with ctDNA and Colorectal Cancer (CRC), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoxiang Cai (86-18017312703, gxcaifuscc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's 2-year Progression-Free Survival (time frame: Two-year Progression-Free Survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.