Actively Recruiting
MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer
Led by Sun Yat-sen University · Updated on 2024-01-12
349
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
G
Guangzhou Burning Rock Dx Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this clinical trial is to test whether minimal residual disease (MRD) status detected by circulating tumor DNA (ctDNA) could be used to guide precision therapy of post-surgery in colon cancer. The colon cancers are intended for resectable colon cancer of high-risk stage II and low-risk stage III status. The main questions it aims to answer are: 1. Whether patients with MRD negative status could benefit from deferred adjuvant therapy. 2. Whether patients with MRD positive status need intensive adjuvant therapy. The qualified participants will go through two different randomized groups according to the post-surgery 1-month MRD status. In MRD negative groups, participants will be divided into standard adjuvant therapy groups and deferred adjuvant therapy groups at 1:2 ratios. In MRD positive groups, participants will be divided into standard adjuvant therapy groups and intensive adjuvant therapy groups at 1:2 ratios. All the patients will receive MRD detection every 3 months and radiological evaluation every 6 months up to 3 years, and survival follow-up up to 5 years.
CONDITIONS
Official Title
MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old at consent
- ECOG physical status score of 0-1 without deterioration within 2 weeks before enrollment
- Histological or cytological confirmed stage II high-risk or stage III low-risk non-MSI-H colon adenocarcinoma
- No evidence of distant metastasis confirmed by comprehensive examination
- Tumor located at least 12 cm from the anal edge
- No prior neoadjuvant therapy and able to achieve R0 radical resection
- Availability of sufficient surgical fresh tissue samples for personalized MRD testing and required blood samples for MRD testing
- Females of childbearing potential must use contraception and not breastfeed during the study period
- Male participants must use barrier contraception during the study period
- Voluntary participation with signed informed consent
- Suitable for CAPEOX and mFOLFOXIRI adjuvant therapy
You will not qualify if you...
- Prior neoadjuvant therapy, systemic chemotherapy, immunotherapy, radiotherapy, or colon cancer surgery
- History or concurrent diagnosis of other malignant tumors except certain skin or cervical cancers
- Histological types other than adenocarcinoma
- MSI-H or deficient mismatch repair status
- Evidence of metastatic lesions
- Multiple primary colorectal cancers
- Recent open surgery not involving the colon within 14 days before enrollment
- Inability to provide required tissue or blood samples for MRD testing
- Serious diseases affecting follow-up or survival
- Medical or social/psychological issues making participation unsuitable
- Recent blood transfusion within 2 weeks before or during surgery
- Inability to afford contrast-enhanced MRI or CT for follow-up
- Recent use of certain Chinese patent medicines with anti-tumor effects
- Serious or uncontrolled systemic diseases including severe mental or neurological disorders, unstable cardiovascular or respiratory conditions
- Recent significant cardiac events or abnormal ECG findings
- Use of drugs known to prolong QT interval within 2 weeks before enrollment
- Insufficient bone marrow or organ function based on laboratory tests
- Pregnancy, lactation, or planning pregnancy during the study
- Other factors judged by researchers as making participant unfit for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
G
Gong Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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