NCT07562490

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
20mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Apr 2025Dec 2027

Study Start

First participant enrolled

April 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

April 26, 2026

Last Update Submit

April 26, 2026

Conditions

ctDNAChemotherapyColorectal Cancer

Outcome Measures

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.

    2 years

Secondary Outcomes (1)

  • ctDNA-clearance Rate

    6 months

Study Arms (2)

doublet chemotherapy group

ACTIVE COMPARATOR

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

Drug: FOLFOX

doublet chemotherapy + BEV group

EXPERIMENTAL

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

FOLFOXDRUG

FOLFOX for 6 months

doublet chemotherapy group
Folfox plus BevacizumabDRUG

FOLFOX plus Bevacizumab for 6 months

doublet chemotherapy + BEV group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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;
  • 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.

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocolBevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Guoxiang Cai

CONTACT

86-18017312703gxcaifuscc@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 1, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)