Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609434
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 radiofrequency ablation The main questions it aims to answer are
Is radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases What medical problems do participants have when treating with radiofrequency ablation Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better
Participants will
Receive systemic treatment for colorectal cancer liver metastases Undergo or not radiofrequency ablation for colorectal cancer liver metastases
Visit the hospital once every 3 months for checkups and tests
Is radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases What medical problems do participants have when treating with radiofrequency ablation Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better
Participants will
Receive systemic treatment for colorectal cancer liver metastases Undergo or not radiofrequency ablation for colorectal cancer liver metastases
Visit the hospital once every 3 months for checkups and tests
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 of the tumor cells through direct thermal effect In recent years many clinical studies have confirmed that RFA is a minimally invasive safe and effective local treatment for liver tumors which has been widely used and studied worldwide This study is for patients with intrahepatic multifocal recurrence after surgery for liver metastasis of colorectal cancer Systemic therapy withwithout radiofrequency ablation will be performed of intrahepatic lesions The feasibility efficacy and safety of the treatment strategy will be evaluated and analyzed through follow-up which will provide a new treatment mode and a basis for clinical decision-making for patients with multiple lesions of progressive colorectal cancer
For patients with multiple intrahepatic metastatic lesions who are not suitable for or refuse to undergo surgical re-resection explore the feasibility of a modality treatment of radiofrequency batch therapy combined with systemic therapy Firstly 2-4 cycles of systemic therapy should be performed and the response to treatment should be evaluated by enhanced CTMRI combined with multimodal ultrasonography and radiofrequency ablation should be performed for patients who have effective systemic therapy Before radiofrequency ablation treatment relevant hematological tests such as blood routine biochemistry coagulation function etc were performed to ensure that the enrollment criteria were met For patients who do not meet the enrollment criteria radiofrequency ablation treatment will be postponed and clinical treatment will be performed until the enrollment criteria are met and those patients who cannot meet the enrollment criteria will be withdrawn from the study Secondly the 2-6 intrahepatic lesions for the first radiofrequency ablation were confirmed according to the ultrasound model and other clinical factors After radiofrequency treatment 1-2 cycles of systemic treatment were carried out and after effective evaluation radiofrequency ablation was performed again for 2-6 foci the selection criteria were the same as the above and so on with a maximum of 3 times of ablations to ablate all the visible foci as far as possible and to achieve a basically no evidence of disease in the liver Systemic therapy was separated from radiofrequency ablation therapy by 1 week to minimize the impact of treatment side effects In the control group patients would be treated with systemic therapy alone without localized treatment
Enhanced CTMRI will be performed 1 month after radiofrequency ablation treatment to evaluate the effectiveness of the technique Ultrasoundcontrast-enhanced ultrasound imaging enhanced CTMRI laboratory tests hematology blood biochemistry tumor markers etc electrocardiogram will be performed every 3 months within 2 years after treatment Ultrasoundcontrast-enhanced ultrasound imaging laboratory tests electrocardiogram will be performed every 3 months and enhanced CTMRI every 6 months after 2 years of treatment
Due to the large number of lesions treated with radiofrequency the occurrence of post-radiofrequency complications is closely monitored as well as the effect on the patients hepatic and renal function after radiofrequency ablation As radiofrequency ablation may reduce the times of systemic therapy it may reduce the toxic side effects of systemic therapy Patients in both groups were tested regularly asked about their condition underwent physical examination recorded vital signs and laboratory indicators electrocardiograms adverse events such as drug side effects and complications of radiofrequency therapy
For patients with multiple intrahepatic metastatic lesions who are not suitable for or refuse to undergo surgical re-resection explore the feasibility of a modality treatment of radiofrequency batch therapy combined with systemic therapy Firstly 2-4 cycles of systemic therapy should be performed and the response to treatment should be evaluated by enhanced CTMRI combined with multimodal ultrasonography and radiofrequency ablation should be performed for patients who have effective systemic therapy Before radiofrequency ablation treatment relevant hematological tests such as blood routine biochemistry coagulation function etc were performed to ensure that the enrollment criteria were met For patients who do not meet the enrollment criteria radiofrequency ablation treatment will be postponed and clinical treatment will be performed until the enrollment criteria are met and those patients who cannot meet the enrollment criteria will be withdrawn from the study Secondly the 2-6 intrahepatic lesions for the first radiofrequency ablation were confirmed according to the ultrasound model and other clinical factors After radiofrequency treatment 1-2 cycles of systemic treatment were carried out and after effective evaluation radiofrequency ablation was performed again for 2-6 foci the selection criteria were the same as the above and so on with a maximum of 3 times of ablations to ablate all the visible foci as far as possible and to achieve a basically no evidence of disease in the liver Systemic therapy was separated from radiofrequency ablation therapy by 1 week to minimize the impact of treatment side effects In the control group patients would be treated with systemic therapy alone without localized treatment
Enhanced CTMRI will be performed 1 month after radiofrequency ablation treatment to evaluate the effectiveness of the technique Ultrasoundcontrast-enhanced ultrasound imaging enhanced CTMRI laboratory tests hematology blood biochemistry tumor markers etc electrocardiogram will be performed every 3 months within 2 years after treatment Ultrasoundcontrast-enhanced ultrasound imaging laboratory tests electrocardiogram will be performed every 3 months and enhanced CTMRI every 6 months after 2 years of treatment
Due to the large number of lesions treated with radiofrequency the occurrence of post-radiofrequency complications is closely monitored as well as the effect on the patients hepatic and renal function after radiofrequency ablation As radiofrequency ablation may reduce the times of systemic therapy it may reduce the toxic side effects of systemic therapy Patients in both groups were tested regularly asked about their condition underwent physical examination recorded vital signs and laboratory indicators electrocardiograms adverse events such as drug side effects and complications of radiofrequency therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None