Status:
NOT_YET_RECRUITING
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Colo-rectal Cancer
Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if radiofrequency ablation works to treat recurrent colorectal cancer liver metastases after surgery in adults. It will also learn about the safety of radio...
Detailed Description
The percutaneous radiofrequency ablation (RFA) is guided by ultrasound imaging to target and locate the tumor, and the ablation electrode needles are inserted into the tumor foci, leading to the death...
Eligibility Criteria
Inclusion
- Patients with colorectal cancer whose primary lesions have been resected or can be controlled;
- Multiple confined lesions in the liver, the number of which can be defined;
- The liver contains at least 2 lesions suitable for radiofrequency ablation;
- The maximum diameter of the intrahepatic tumor is \<5 cm;
- The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;
- No extrahepatic metastases or stable extrahepatic metastases;
- Re-operative hepatic surgical resection is not indicated or refused;
- Ultrasound or ultrasonography can show intrahepatic lesions;
- The patient and his/her family request active treatment;
- Voluntary informed consent;
- Male or female at least 18 years of age;
- Platelet count \>50, 000/mm3 and prothrombin activity \>50%;
- Subjects are willing to return to the study center for study follow-up;
- Life expectancy ≥ 6 months.
Exclusion
- 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;
- Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;
- Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;
- Have portal or hepatic vein tumor infiltration/cancer embolism;
- Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center;
- Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL;
- Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 ml/min;
- Serum bilirubin \>3.0 mg/dL;
- Serum albumin \<2.8 g/dL;
- Body temperature \>101°F (38.3°C) immediately prior to study treatment;
- Being treated with other investigational drugs;
- Heart failure NYHA functional class III or IV.
- Any other circumstances that the investigator deems inappropriate for enrollment.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT06609434
Start Date
October 1 2024
End Date
December 1 2026
Last Update
September 27 2024
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