Colorectal CarcinomaNCT04562727
Microwave Ablation Combined With Chemotherapy for Colorectal Liver Metastases： a Multicenter Cohort Study
A study testing Chemotherapy in people with Colorectal Carcinoma and Chemotherapy, run by Ping Liang.
Trial summary
Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Carcinoma, Chemotherapy, Liver Metastases
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Aged between 18 and 80, WHO physical status score < level 2
- 2) Histologically confirmed colorectal cancer, liver metastasis (≤4), maximum diameter ≤4cm;
- 3) Patients without extrahepatic metastasis;
- 4) If the primary tumor has been resected or has metastasized at the same time, the multidisciplinary panel determines that the primary tumor can be resected and resected within one month after ablation;
- 5) No other chemotherapy experience except anti-tumor treatment for the primary cancer;
- 6) The main organs function normally, that is, they meet the following standards:
- Blood routine examination: HB≥90 g/L; The ANC acuity 1.5 x 109 / L; PLT 60 x 109 / L or higher;
- Biochemical examination: ALB ≥29g/L; ALT and AST < 3 uln; 1.5 ULN TBIL or less; Creatinine 1.5 or less ULN.
Who cannot join
- 1) A history of other malignant tumors in the past 5 years;
- 2) Cardiovascular diseases with significant clinical symptoms (uncontrolled congestive heart failure, angina pectoris, hypertension, arrhythmia);
- 3) Persons with coagulation disorders;
- 4) Combined with active infection;
- 5) Those with any contraindications related to chemotherapy;
- 6) Pregnant or lactating women;
- 7) A history of substance abuse and mental illness;
- 8) The investigator believes that there are any other factors that are not suitable for inclusion or affect the subject's participation in the study.
Trial locations and contacts
No sites are listed yet.
Ping Liang, Doctor contact
About this study
Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection. Many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Chemotherapy can kill the microscopic cancer foci of the liver. The timing of ablation-related chemotherapeutic administration still needs to be explained.
The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colorectal cancer with liver metastasis.
Read the detailed description
Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection.
In the early 1990s, radiofrequency ablation (RFA) was first applied in the treatment of liver metastases. In the late 1990s and early 2000s, microwave ablation (MWA), irreversible electroporation (IRE) and other technologies emerged. Today, with the continuous improvement of ablation techniques, many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Currently, institutions have conducted multi-center randomized controlled trials to compare the outcomes of the two treatment approaches. The expert consensus of tumor ablation therapy has confirmed that the ablation technique has the advantages of minimally invasive, well tolerated and low complications, and has been widely used in the treatment of solid tumors. In the treatment of liver metastases, it also has the advantage of not being limited by residual liver volume.
Postoperative tumor recurrence occurred in about 2/3 of the patients with liver stump, mainly due to the residual microscopic cancer foci. Chemotherapy can kill the microscopic cancer foci of the liver. EORTC (40983) confirmed that: compared with surgery alone, perioperative chemotherapy for resectable liver metastases (<4) could benefit patients with PFS and reduce the incidence of tumor progression-related events. EORTC (40004) proved that in the treatment of non-resectable liver metastases (1 ~ 10, with a maximum diameter <4cm), ablation combined with postoperative chemotherapy was superior to chemotherapy alone. E. Tanis et al compared two randomized controlled trials of EORTC for colorectal cancer liver metastasis, namely 40983 (EPOC) and 40004 (CLOCC), and confirmed the treatment of liver metastasis (<3cm) after integration. There was no significant difference in local recurrence rate between the RFA+ postoperative chemotherapy group and the surgery + perioperative chemotherapy group. At the beginning, neoadjuvant chemotherapy was designed to provide surgical resection opportunities for patients who could not be resected with metastatic tumor. Later, it was gradually applied to resectable liver metastasis. Studies on surgical combination with chemotherapy proved that preoperative chemotherapy was no less effective than postoperative chemotherapy for resectable liver metastasis. However, for isolated small metastatic tumors (<3cm), complete tumor response after neoadjuvant chemotherapy should be avoided, leading to the dilemma of inoperable. Studies have reported that ablation combined with preoperative chemotherapy can cause hepatic steatosis and tumor shrinkage, which makes tumor visualization difficult to a certain extent. If the tumor disappeared on imaging, the pathological specimen confirmed that there were still residues, and the tumor could "reappear" during follow-up. Therefore, the timing of ablation-related chemotherapeutic administration still needs to be explained, and there is still a lack of high-quality evidence-based medical evidence at home and abroad.
The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colon cancer with liver metastasis.
- Conditions
- Colorectal Carcinoma, Chemotherapy, Liver Metastases
- Being tested
- Chemotherapy
- Keywords
- Microwave Ablation, Colorectal liver metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called preoperative chemotherapy, postoperative chemotherapy
perioperative chemotherapy or postoperative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Only MWA | Experimental | Only preform MWA, chemotherapy isn't necessary Receives: Drug: Chemotherapy |
| MWA combined with perioperative chemotherapy | Active comparator | MWA combined with perioperative chemotherapy. Chemotherapy was preformed before MWA and after MWA Receives: Drug: Chemotherapy |
| MWA combined with postoperative chemotherapy | Experimental | MWA combined with perioperative chemotherapy. Chemotherapy was preformed after MWA Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
From the beginning of randomization to the time of disease recurrence or death due to disease progression
Measured: 60 months
Secondary outcomes (5)
OS
Time from randomization to death from any cause.
Measured: 60 months
ORR
Proportion of patients whose tumors shrink to a certain extent and remain constant for a certain period of time, including cases of complete response (CR) and partial response (PR).
Measured: 60 months
LTP
From the beginning of randomization to the time of disease progression or death.
Measured: 60 months
CSS
After treatment, death caused by tumor was considered as the end point, and the proportion of patients still alive after several years of follow-up accounted for the total number of follow-up patients.
Measured: 60 months
Tumor reactivity assessment
Tumor reactivity assessment by mRECIST
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ping Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562727
- Sponsor's protocol ID
- S2020-266-01
- Status last verified
- Mar 2021
- First submitted
- 6 Sep 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Pang C, Liu G, Xie X, Zhang DZ, Li K, Li Z, He G, Xu E, Zhong H, Yang H, Lu M, Lou K, Xie X, Lan S, Li Q, Dai G, Yu J, Liang P. Thermal ablation with and without adjuvant systemic therapy: a nationwide multicenter observational cohort study of solitary colorectal liver metastases. Int J Surg. 2024 Jul 1;110(7):4240-4248. doi: 10.1097/JS9.0000000000001397.
PubMed 38597399
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation Combined With Chemotherapy for Colorectal Liver Metastases： a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04562727
- Acronym / sponsor ID
- S2020-266-01
- Conditions
- Colorectal Carcinoma, Chemotherapy, Liver Metastases
- Keywords
- Microwave Ablation, Colorectal liver metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- Ping LiangUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Sep 2020 (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.
Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection. Many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Chemotherapy can kill the microscopic cancer foci of the liver. The timing of ablation-related chemotherapeutic administration still needs to be explained.
The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colorectal cancer with liver metastasis.
Detailed description
Colorectal cancer is the second deadliest malignant tumor worldwide, and liver is the most common site of hematogenic metastasis of Colorectal cancer. Surgery is an effective treatment for colorectal cancer with liver metastasis, however, only 10%-20% of patients with liver metastasis are feasible for radical surgical resection.
In the early 1990s, radiofrequency ablation (RFA) was first applied in the treatment of liver metastases. In the late 1990s and early 2000s, microwave ablation (MWA), irreversible electroporation (IRE) and other technologies emerged. Today, with the continuous improvement of ablation techniques, many single-center retrospective studies have demonstrated that thermal ablation for liver metastases is comparable to surgery. Currently, institutions have conducted multi-center randomized controlled trials to compare the outcomes of the two treatment approaches. The expert consensus of tumor ablation therapy has confirmed that the ablation technique has the advantages of minimally invasive, well tolerated and low complications, and has been widely used in the treatment of solid tumors. In the treatment of liver metastases, it also has the advantage of not being limited by residual liver volume.
Postoperative tumor recurrence occurred in about 2/3 of the patients with liver stump, mainly due to the residual microscopic cancer foci. Chemotherapy can kill the microscopic cancer foci of the liver. EORTC (40983) confirmed that: compared with surgery alone, perioperative chemotherapy for resectable liver metastases (<4) could benefit patients with PFS and reduce the incidence of tumor progression-related events. EORTC (40004) proved that in the treatment of non-resectable liver metastases (1 ~ 10, with a maximum diameter <4cm), ablation combined with postoperative chemotherapy was superior to chemotherapy alone. E. Tanis et al compared two randomized controlled trials of EORTC for colorectal cancer liver metastasis, namely 40983 (EPOC) and 40004 (CLOCC), and confirmed the treatment of liver metastasis (<3cm) after integration. There was no significant difference in local recurrence rate between the RFA+ postoperative chemotherapy group and the surgery + perioperative chemotherapy group. At the beginning, neoadjuvant chemotherapy was designed to provide surgical resection opportunities for patients who could not be resected with metastatic tumor. Later, it was gradually applied to resectable liver metastasis. Studies on surgical combination with chemotherapy proved that preoperative chemotherapy was no less effective than postoperative chemotherapy for resectable liver metastasis. However, for isolated small metastatic tumors (<3cm), complete tumor response after neoadjuvant chemotherapy should be avoided, leading to the dilemma of inoperable. Studies have reported that ablation combined with preoperative chemotherapy can cause hepatic steatosis and tumor shrinkage, which makes tumor visualization difficult to a certain extent. If the tumor disappeared on imaging, the pathological specimen confirmed that there were still residues, and the tumor could "reappear" during follow-up. Therefore, the timing of ablation-related chemotherapeutic administration still needs to be explained, and there is still a lack of high-quality evidence-based medical evidence at home and abroad.
The purpose of this study was to compare the clinical efficacy of thermal ablation or combined with perioperative chemotherapy and postoperative chemotherapy in the treatment of colon cancer with liver metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Only MWA | Experimental | Drug: ChemotherapyOnly preform MWA, chemotherapy isn't necessary |
| MWA combined with perioperative chemotherapy | Active comparator | Drug: ChemotherapyMWA combined with perioperative chemotherapy. Chemotherapy was preformed before MWA and after MWA |
| MWA combined with postoperative chemotherapy | Experimental | Drug: ChemotherapyMWA combined with perioperative chemotherapy. Chemotherapy was preformed after MWA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) Aged between 18 and 80, WHO physical status score < level 2
- 2) Histologically confirmed colorectal cancer, liver metastasis (≤4), maximum diameter ≤4cm;
- 3) Patients without extrahepatic metastasis;
- 4) If the primary tumor has been resected or has metastasized at the same time, the multidisciplinary panel determines that the primary tumor can be resected and resected within one month after ablation;
- 5) No other chemotherapy experience except anti-tumor treatment for the primary cancer;
Key exclusion criteria (8 listed)
- 1) A history of other malignant tumors in the past 5 years;
- 2) Cardiovascular diseases with significant clinical symptoms (uncontrolled congestive heart failure, angina pectoris, hypertension, arrhythmia);
- 3) Persons with coagulation disorders;
- 4) Combined with active infection;
- 5) Those with any contraindications related to chemotherapy;
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 |
|---|---|---|
| ChemotherapyAlso: preoperative chemotherapy, postoperative chemotherapyperioperative chemotherapy or postoperative chemotherapy | Drug | MWA combined with perioperative chemotherapy, MWA combined with postoperative chemotherapy, Only MWA |
Primary outcome
DFS
Time frame: 60 months
From the beginning of randomization to the time of disease recurrence or death due to disease progression
5 secondary outcomes
OS
Time frame: 60 months
ORR
Time frame: 60 months
LTP
Time frame: 60 months
CSS
Time frame: 60 months
Tumor reactivity assessment
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 38597399Li J, Pang C, Liu G, Xie X, Zhang DZ, Li K, Li Z, He G, Xu E, Zhong H, Yang H, Lu M, Lou K, Xie X, Lan S, Li Q, Dai G, Yu J, Liang P. Thermal ablation with and without adjuvant systemic therapy: a nationwide multicenter observational cohort study of solitary colorectal liver metastases. Int J Surg. 2024 Jul 1;110(7):4240-4248. doi: 10.1097/JS9.0000000000001397.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ping Liang, Doctor contact
Ping Liang, Doctor principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy in people with Colorectal Carcinoma and Chemotherapy, run by Ping Liang.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jianming Li, Dr (860118810611944, lijianming@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562727, which also lists 1 linked publication.
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 4 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.