Colo-rectal CancerNCT06609434
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
A study testing Radiofrequency ablation in people with Colo-rectal Cancer and Liver Metastasis, run by Peking University Cancer Hospital & Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Liver Metastasis
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hong Wang, PhD contact
About this study
Official title: The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery
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.
Read more
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.
Read the 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 with/without 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 CT/MRI 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 CT/MRI will be performed 1 month after radiofrequency ablation treatment to evaluate the effectiveness of the technique. Ultrasound/contrast-enhanced ultrasound imaging, enhanced CT/MRI, laboratory tests (hematology, blood biochemistry, tumor markers, etc.), electrocardiogram will be performed every 3 months within 2 years after treatment. Ultrasound/contrast-enhanced ultrasound imaging, laboratory tests, electrocardiogram will be performed every 3 months and enhanced CT/MRI 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 patient's 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.
- Conditions
- Colo-rectal Cancer, Liver Metastasis
- Being tested
- Radiofrequency ablation
- Keywords
- Colo-rectal cancer, Liver Metastasis, radiofrequency ablation
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
This study is the first to apply radiofrequency ablation to multiple recurrent intrahepatic lesions of colorectal cancer liver metastases.
| Study group | Role | What they receive |
|---|---|---|
| systemic therapy | No intervention | This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy. |
| systemic therapy combined with radiofrequency ablation | Experimental | This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy combined with radiofrequency ablation. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver progression-free survival
Time from initial treatment to intrahepatic disease progression or patient death
Measured: 2 years
Secondary outcomes (1)
overall survival
Time from initial treatment to patient death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was divided into two groups, the interventional group was: systemic therapy combined with radiofrequency therapy, the control group was: systemic therapy alone.
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Yang, PhD, Principal investigator, Peking University Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609434
- Sponsor's protocol ID
- 2024-2-2157
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery
- ClinicalTrials.gov ID
- NCT06609434
- Acronym / sponsor ID
- 2024-2-2157
- Conditions
- Colo-rectal Cancer, Liver Metastasis
- Keywords
- Colo-rectal cancer, Liver Metastasis, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 with/without 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 CT/MRI 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 CT/MRI will be performed 1 month after radiofrequency ablation treatment to evaluate the effectiveness of the technique. Ultrasound/contrast-enhanced ultrasound imaging, enhanced CT/MRI, laboratory tests (hematology, blood biochemistry, tumor markers, etc.), electrocardiogram will be performed every 3 months within 2 years after treatment. Ultrasound/contrast-enhanced ultrasound imaging, laboratory tests, electrocardiogram will be performed every 3 months and enhanced CT/MRI 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 patient's 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was divided into two groups, the interventional group was: systemic therapy combined with radiofrequency therapy, the control group was: systemic therapy alone.
| Arm | Type | Receives |
|---|---|---|
| systemic therapy | No intervention | –This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy. |
| systemic therapy combined with radiofrequency ablation | Experimental | Procedure: Radiofrequency ablationThis arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy combined with radiofrequency ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationThis study is the first to apply radiofrequency ablation to multiple recurrent intrahepatic lesions of colorectal cancer liver metastases. | Procedure or surgery | systemic therapy combined with radiofrequency ablation |
Primary outcome
liver progression-free survival
Time frame: 2 years
Time from initial treatment to intrahepatic disease progression or patient death
1 secondary outcome
overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Colo-rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Wang, PhD contact
Wei Yang, PhD principal investigator
Peking University Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Colo-rectal Cancer and Liver Metastasis, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Yang, PhD (646 750 9871, 13681408183@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.