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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT06609434
Eligibility Criteria:
Inclusion Criteria:
1. Patients with colorectal cancer whose primary lesions have been resected or can be controlled;
2. Multiple confined lesions in the liver, the number of which can be defined;
3. The liver contains at least 2 lesions suitable for radiofrequency ablation;
4. The maximum diameter of the intrahepatic tumor is \<5 cm;
5. The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;
6. No extrahepatic metastases or stable extrahepatic metastases;
7. Re-operative hepatic surgical resection is not indicated or refused;
8. Ultrasound or ultrasonography can show intrahepatic lesions;
9. The patient and his/her family request active treatment;
10. Voluntary informed consent;
11. Male or female at least 18 years of age;
12. Platelet count \>50, 000/mm3 and prothrombin activity \>50%;
13. Subjects are willing to return to the study center for study follow-up;
14. Life expectancy ≥ 6 months.
Exclusion Criteria:
1. Suffering from, but not limited to, the following serious illnesses: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening cardiac arrhythmia within the last 6 months;
2. Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;
3. Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;
4. Have portal or hepatic vein tumor infiltration/cancer embolism;
5. Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center;
6. Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL;
7. Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 ml/min;
8. Serum bilirubin \>3.0 mg/dL;
9. Serum albumin \<2.8 g/dL;
10. Body temperature \>101°F (38.3°C) immediately prior to study treatment;
11. Being treated with other investigational drugs;
12. Heart failure NYHA functional class III or IV.
13. Any other circumstances that the investigator deems inappropriate for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06609434
Study Brief:
Protocol Section:
NCT06609434