NCT06167967 Circulating Tumor DNA Methylation Guiding Postoperative Adjuvant Chemotherapy in Stage III Colorectal Cancer
| NCT ID | NCT06167967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sir Run Run Shaw Hospital |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 990 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 990 participants in total. It began in 2024-04-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized controlled trial is to investigate whether ctDNA methylation is a more precise indicator to guide postoperative adjuvant chemotherapy in stage Ill colorectal cancer. The main questions it aims to answer are: 1. Whether ctDNA methylation-guided escalation strategy is superior to standard treatment for stage III high-risk CRC patients. 2. Whether ctDNA methylation-guided de-escalation strategy is non-inferior to standard treatment for stage III low-risk CRC patients. 325 cases were included in the high-risk cohort (T4 and/or N2) and 665 cases were included in the low-risk cohort (T1-T3, N1). Then patients in each cohort were randomly assigned to ctDNA-guided treatment (ctDNA-guided group) and standard treatment (standard treatment group) in a ratio of 2:1. The standard treatment group and ctDNA-negative group in the high-risk cohort were treated with XELOX regimen for 6 months, and the ctDNA-positive group in the high-risk cohort was treated with cmFOLFOXIRI regimen for 6 months. The standard treatment group and the ctDNA-positive group in the low-risk cohort were treated with XELOX regimen for 3 months, while the ctDNA-negative group in the low-risk cohort did not receive adjuvant chemotherapy.
Eligibility Criteria
Inclusion Criteria: 1. 18 years old ≤ age \< 75 years old. 2. Stage III (T1-4, N1-2, M0) colorectal cancer patients. 3. Patients who can undergo R0 resection. 4. ECOG score 0 \~ 2. 5. Expected survival ≥ 6 months. 6. No history of other malignant tumors. 7. Voluntarily participate in this study and sign the informed consent. If the subject does not have the ability to read the informed consent (e.g., illiterate subjects), a witness must witness the informed process and sign the informed consent. Exclusion Criteria: 1. Patients who have received neoadjuvant chemotherapy. 2. Known high clinical risk of adjuvant chemotherapy. 3. Patients with clear contraindications to adjuvant chemotherapy (i.e. due to physical condition, comorbidities, active second cancer, or age). 4. Patients who are unable to undergo subsequent chemotherapy due to other reasons (travel distance, compliance). 5. Vulnerable groups, including people with mental illness, people with cognitive impairment, critically ill patients, minors, pregnant women, etc. 6. There are any other circumstances that the researcher deems unsuitable for inclusion.
Contact & Investigator
Zhangfa Song, Dr
PRINCIPAL INVESTIGATOR
Sir Run Run Shaw Hospital
Frequently Asked Questions
Who can join the NCT06167967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06167967 currently recruiting?
Yes, NCT06167967 is actively recruiting participants. Contact the research team at echobai@zju.edu.cn for enrollment information.
Where is the NCT06167967 trial being conducted?
This trial is being conducted at Hanzhou, China.
Who is sponsoring the NCT06167967 clinical trial?
NCT06167967 is sponsored by Sir Run Run Shaw Hospital. The principal investigator is Zhangfa Song, Dr at Sir Run Run Shaw Hospital. The trial plans to enroll 990 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.