Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT05427669
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-70 years old
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
3. ECOG performance status 0-1
4. Upfront surgery (R0 resection) and postoperative pathological stage II -III and the circulating tumor DNA (ctDNA) test results show that MRD was positive
5. Randomization must be within 8 weeks after surgery.
6. No distant metastasis after surgery
7. Appropriate organ function
Exclusion Criteria:
1. Postoperative CT scan showed distant meatstasis
2. Patients with postoperative obstruction or active bleeding
3. Other active malignant tumors in the past or at the same time (except for malignant tumors that have received curative treatment and have no disease for more than 5 years or carcinoma in situ that can be cured by adequate treatment)
4. The time from postoperative to start of adjuvant therapy has exceeded 8 weeks
5. Patients who have received neoadjuvant therapy
6. Active coronary artery disease, severe/unstable angina or newly diagnosed angina or myocardial infarction within 12 months prior to study participation
7. Thrombotic or embolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis
8. Unstable or any medical condition that affects patient safety and study compliance
9. Subjects with known allergy to the study drugs or to any of its excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05427669
Study Brief:
Protocol Section:
NCT05427669