Actively Recruiting
Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer
Led by Fudan University · Updated on 2026-05-01
80
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with expected survival over 3 months
- Histologically confirmed postoperative high-risk stage II colorectal cancer
- Positive ctDNA status one month after surgery
- Expected survival over 12 months
- Ability and willingness to provide informed consent
You will not qualify if you...
- Received neoadjuvant therapy before surgery
- Blood transfusion during surgery or within 2 weeks before surgery
- Pregnant or breastfeeding, or of reproductive potential without adequate contraception
- History of other cancers within 5 years, except treated carcinoma in situ of cervix or non-melanoma skin cancer
- Uncontrolled brain tumors or central nervous system metastases, or significant intracranial hypertension or neuropsychiatric symptoms
- Severe or uncontrolled comorbidities including unstable cardiac disease, neurological or psychiatric disorders, severe infections, active disseminated intravascular coagulation, significant bleeding tendency, or major organ impairment
- Any condition deemed unsuitable by the investigator
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
G
Guoxiang Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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