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RecruitingNCT07562490CLEAR-04Updated May 1, 2026

A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer

A Phase 2 interventional study of FOLFOX and Folfox plus Bevacizumab in ctDNA, Chemotherapy and Colorectal Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2025, registered Apr 2026).
  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • ctDNA
  • Chemotherapy
  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    doublet chemotherapy group

    Patients with T4N+ or T1-3N2 disease assigned to control group will receive FOLFOX/CAPOX for 6 months

    Drug: FOLFOX

  • Experimental
    doublet chemotherapy + BEV group

    Patients with T4N+ or T1-3N2 disease assigned to intervention group will receive FOLFOX/CAPOX plus bevacizumab for 6 months

    Drug: Folfox plus Bevacizumab

Interventions

  • DrugFOLFOX

    FOLFOX for 6 months

  • DrugFolfox plus Bevacizumab

    FOLFOX plus Bevacizumab for 6 months

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07562490
Lead sponsor
Fudan University
Responsible party
Guoxiang Cai (Fudan University Shanghai Cancer Center, Fudan University) — Principal investigator
First posted
May 1, 2026
Start date
Apr 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 1, 2026

Study contacts

Guoxiang Cai
Contact
gxcaifuscc@163.com
86-18017312703

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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