Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer

NCT07562503 | Recruiting Phase 2

• 2 other identifiers: 2410-Exp102U25A20115
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.

Conditions

ctDNA; Colorectal Cancer; Chemotherapy

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)

3-month doublet chemotherapy group

ACTIVE COMPARATOR

Patients in this group will get FOLFOX/CAPOX for 3 months

Drug: CAPEOX regimen

6-month doublet chemotherapy group

EXPERIMENTAL

Patients assigned to the intervention group will receive adjuvant therapy with either FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.

Drug: CAPEOX regimen

Interventions

CAPEOX regimen DRUG

CAPEOX regimen for 3 months

3-month doublet chemotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Guoxiang Cai

CONTACT

86-18017312703; gxcaifuscc@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: November 1, 2024
• 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)