Overall SurvivalMALRICNCT06462742
Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma
An observational study of Overall Survival and Disease-free Survival, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overall Survival, Disease-free Survival
- What is being tested?
- Microwave ablation (MWA) versus Liver Resection (LR)
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 1 Jun 2029
- Phase
- Observational
- 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
Study population: Chinese patients pathologically diagnosed with intrahepatic cholangiocarcinoma
Who may be able to join
- pathologically diagnosed iCCA based on the WHO classifications;
- curative-intent liver resection or microwave ablation;
- tumor within Milan criteria, namely single tumor ≤5cm in maximum diameter; multiple tumors ≤3 in number and each ≤3cm; no evidence of major vascular/hilar invasion, extrahepatic/lymphatic metastasis or other malignancies;
- age ≥18 years.
Who cannot join
- Patients not meeting any one of the inclusion criteria were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Official title: Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma Within Milan Criteria
Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:
- Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA
- What is the risk factor for ablation or surgery in treating iCCA
- What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.
- Conditions
- Overall Survival, Disease-free Survival
- Being tested
- Microwave ablation (MWA) versus Liver Resection (LR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablation (MWA) versus Liver Resection (LR)Procedure or surgery
Microwave ablation (MWA) is one of the newer modality of thermal ablation and has proven its safety and efficacy in the management of the tumors amenable for ablation for primary and metastatic diseases.
Liver resection is a surgery to remove part of the liver to eradicate tumors.
| Study group | Role | What they receive |
|---|---|---|
| MWA | iCCA patients who underwent microwave ablation (MWA). Receives: Procedure: Microwave ablation (MWA) versus Liver Resection (LR) | |
| LR | iCCA patients who underwent liver resection (LR) Receives: Procedure: Microwave ablation (MWA) versus Liver Resection (LR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
Measured: More than 3 years]
Disease-free survival
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
Measured: More than 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2009
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (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 Overall SurvivalStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462742
- Sponsor's protocol ID
- S2024-0606
- Acronym
- MALRIC
- Status last verified
- Jul 2024
- First submitted
- 12 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pang C, Li J, An C, Wang Z, Li Z, Chen Q, Qi R, Xiao F, Liu J, Gao X, Li M, Lv H, Li D, Liu X, Hua G, Yang M, Liang F, Yu J, Liang P. Survival Outcomes of Microwave Ablation Compared with Repeat Liver Resection in the Treatment of Recurrent Intrahepatic Cholangiocarcinoma. Radiology. 2026 Jan;318(1):e243254. doi: 10.1148/radiol.243254.
PubMed 41528222
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma Within Milan Criteria
- ClinicalTrials.gov ID
- NCT06462742
- Acronym / sponsor ID
- MALRIC / S2024-0606
- Conditions
- Overall Survival, Disease-free Survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 17 Jun 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.
Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:
- Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA
- What is the risk factor for ablation or surgery in treating iCCA
- What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWA | – | Procedure: Microwave ablation (MWA) versus Liver Resection (LR)iCCA patients who underwent microwave ablation (MWA). |
| LR | – | Procedure: Microwave ablation (MWA) versus Liver Resection (LR)iCCA patients who underwent liver resection (LR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients pathologically diagnosed with intrahepatic cholangiocarcinoma
Key inclusion criteria (4 listed)
- pathologically diagnosed iCCA based on the WHO classifications;
- curative-intent liver resection or microwave ablation;
- tumor within Milan criteria, namely single tumor ≤5cm in maximum diameter; multiple tumors ≤3 in number and each ≤3cm; no evidence of major vascular/hilar invasion, extrahepatic/lymphatic metastasis or other malignancies;
- age ≥18 years.
Key exclusion criteria (1 listed)
- Patients not meeting any one of the inclusion criteria were excluded.
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 |
|---|---|---|
| Microwave ablation (MWA) versus Liver Resection (LR)Microwave ablation (MWA) is one of the newer modality of thermal ablation and has proven its safety and efficacy in the management of the tumors amenable for ablation for primary and metastatic diseases. Liver resection is a surgery to remove part of the liver to eradicate tumors. | Procedure or surgery | LR, MWA |
Primary outcome
Overall survival
Time frame: More than 3 years]
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
Disease-free survival
Time frame: More than 3 years
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
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 25 Jul 2024.
- Derived from this study: PubMed 41528222Pang C, Li J, An C, Wang Z, Li Z, Chen Q, Qi R, Xiao F, Liu J, Gao X, Li M, Lv H, Li D, Liu X, Hua G, Yang M, Liang F, Yu J, Liang P. Survival Outcomes of Microwave Ablation Compared with Repeat Liver Resection in the Treatment of Recurrent Intrahepatic Cholangiocarcinoma. Radiology. 2026 Jan;318(1):e243254. doi: 10.1148/radiol.243254.
- Individual participant dataSharing planned: No
Related trials for Overall Survival
Enrolling by invitationObservational study
Liver Transplantation Versus Conventional Medical Therapy for Low-Grade GEP-NET With Liver Metastases
Neuroendocrine Tumors
RecruitingObservational study
Prospective Multicenter Cohort Study of Clinical and Molecular Biomarkers in Colorectal Cancer
Colorectal Neoplasms
RecruitingObservational study
Toxicity of Intensive First-Line Treatment for Adult Burkitt Lymphoma: A Retrospective Observational Study
Adult Burkitt Lymphoma, Chemotherapy-Related Toxicity
Recruiting
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
Active, not recruitingPhase 2
A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments
Unresectable Gastrointestinal Stromal Tumor (GIST), Locally Advanced Gastrointestinal Stromal Tumor (GIST)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overall Survival and Disease-free Survival, run by Chinese PLA General Hospital at 1 site in China.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chuan Pang, Doctor (+86-18910527022, pcpang117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: More than 3 years]). The study lists 2 primary outcomes in all. 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 NCT06462742, 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 25 Jul 2024.