Colorectal CancerNCT05462470
Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
An observational study of Colorectal Cancer and Liver Metastases, run by Fudan University.
Trial summary
For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Repeat Liver Surgery and Non-Repeat Liver Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 30 Apr 2022
- Phase
- Observational
- 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
Study population: patients with initially unresectable colorectal liver metastasis (IU-CRLM) underwent hepatectomy after conversion therapy
Who may be able to join
- initially unresectable colorectal liver metastasis (IU-CRLM)
- received conversion therapy
- underwent conversion hepatectomy
Who cannot join
- the histologic type of CRLM was not called adenocarcinoma
- uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis
- history of previous hepatectomy
- the primary tumor was not resected or palliative resection
- R1 or R2 liver resection
About this study
For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Repeat Liver Surgery, Non-Repeat Liver Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat Liver SurgeryProcedure or surgery
repeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA)
Non-Repeat Liver SurgeryProcedure or surgery
Systemic palliative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| repeat liver surgery | repeat liver surgery for liver relapse lesions Receives: Procedure: Repeat Liver Surgery | |
| non-repeat liver surgery | non-repeat liver surgery, just only systemic palliative chemotherapy Receives: Procedure: Non-Repeat Liver Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival after the first resection of liver metastatic lesions
Measured: 5 years
Secondary outcomes (3)
first relapse free survival
relapse free survival after the first resection of liver metastatic lesions
Measured: 5 years
second relapse free survival
relapse free survival after the repeat liver surgery of liver metastatic lesions
Measured: 5 years
Severe complication rate after resection of primary and metastatic lesions
Grade of III-V complication rate according to Clavien-Dindo
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jan 2008
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Retrospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, MD, Principal investigator, Department of General Surgery, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462470
- Sponsor's protocol ID
- IU-CRLM
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
- ClinicalTrials.gov ID
- NCT05462470
- Acronym / sponsor ID
- IU-CRLM
- Conditions
- Colorectal Cancer, Liver Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Jul 2022 (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.
For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repeat liver surgery | – | Procedure: Repeat Liver Surgeryrepeat liver surgery for liver relapse lesions |
| non-repeat liver surgery | – | Procedure: Non-Repeat Liver Surgerynon-repeat liver surgery, just only systemic palliative chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with initially unresectable colorectal liver metastasis (IU-CRLM) underwent hepatectomy after conversion therapy
Key inclusion criteria (3 listed)
- initially unresectable colorectal liver metastasis (IU-CRLM)
- received conversion therapy
- underwent conversion hepatectomy
Key exclusion criteria (5 listed)
- the histologic type of CRLM was not called adenocarcinoma
- uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis
- history of previous hepatectomy
- the primary tumor was not resected or palliative resection
- R1 or R2 liver resection
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 |
|---|---|---|
| Repeat Liver Surgeryrepeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA) | Procedure or surgery | repeat liver surgery |
| Non-Repeat Liver SurgerySystemic palliative chemotherapy | Procedure or surgery | non-repeat liver surgery |
Primary outcome
overall survival
Time frame: 5 years
Overall survival after the first resection of liver metastatic lesions
3 secondary outcomes
first relapse free survival
Time frame: 5 years
second relapse free survival
Time frame: 5 years
Severe complication rate after resection of primary and metastatic lesions
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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.
Jianmin Xu, MD principal investigator
Department of General Surgery, Zhongshan Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastases, run by Fudan University.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 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 19 Jul 2022.