Colon Cancer Liver MetastasesNCT06069960
SALT for Unresectable Colorectal Liver Metastases
A study testing sequential adult left lateral lobe liver transplantation (SALT) in people with Colon Cancer Liver Metastases, run by RenJi Hospital.
Trial summary
Colon cancer is a common malignancy with a low survival rate worldwide, and unresectable colon cancer liver metastases (ICRLM) have a worse prognosis. The liver is the most common metastatic organ of colorectal cancer, and palliative chemotherapy is the only option for most ICRLM patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer Liver Metastases
- What is being tested?
- sequential adult left lateral lobe liver transplantation (SALT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 30 Jun 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75;
- Physical fitness status (ECOG) 0~1;
- Histologically confirmed primary colorectal neoplasm. The time from primary colorectal tumor resection to transplantation is ≥3 months and the stage of primary colorectal tumor is ≤T3N1. Accept T4N0 or T4N2 if primary tumor resection interval is ≥ 2 years
- Liver metastases (CRLM) located in bilateral livers, or limited to liver and unresectable CRLM after discussion by MDT;
- According to PET/CT, CT and MRI, there are no other abdominal metastases except the liver or 1-3 resectable lung metastases;
- Patients have received at least 6-8 weeks of first-line chemotherapy at the time of screening. According to RECIST criteria, CRLM was stable or partially regressed during and after treatment (still not completely resectable);
- The CEA (carcinoembryonic antigen) value before screening is ≤80 µg/L or the highest level after treatment is reduced by ≥ 50%;
- Sign the informed consent form.
Who cannot join
- Extrahepatic tumor burden (except for resectable lung metastases) and/or large vessel tumor infiltration;
- The largest liver tumor lesion >5.5cm at the time of screening;
- Tumor progression during chemotherapy or severe comorbidities that make transplantation impossible;
- BRAF mutation and/or microsatellite instability primary tumor (MSI);
- Suffering from other primary malignant tumors in the past 5 years;
- Cardiopulmonary disease that cannot be corrected, with high surgical risk, or anatomical abnormality that makes liver transplantation impossible;
Show all 10Show fewer
- Substance abuse, medical, psychological or social conditions may interfere with the patient's participation in the study or evaluation of the study results;
- Combined with AIDS and other diseases that affect surgery or tumor progression;
- Pregnant or lactating patients;
- Other reasons that the researchers think are not suitable for participation.
About this study
Official title: Sequential Adult Left Lateral Lobe Liver Transplantation (SALT) in Patients With Unresectable Colorectal Liver Metastases: a Single-center, Prospective, Single-arm Study
Colon cancer is a common malignancy with a low survival rate worldwide, and unresectable colon cancer liver metastases (ICRLM) have a worse prognosis. The liver is the most common metastatic organ of colorectal cancer, and palliative chemotherapy is the only option for most ICRLM patients. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%. Liver transplantation is an ideal choice for patients with ICRLM, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of iCRLM. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.
Read the detailed description
Colorectal cancer is currently the third most common malignant tumor in the world, and about 20%-50% of patients have liver metastases at the time of diagnosis or progress to liver metastases thereafter. The liver is the most frequently invaded organ by colorectal cancer, and liver resection is considered to be the best and only treatment option for patients with colorectal liver metastases (CLMs). However, only about 20% of patients are candidates for radical hepatectomy. For most patients who are not candidates for hepatectomy, palliative chemotherapy is the only option. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%.
Theoretically, liver transplantation is an ideal choice for patients with unresectable colorectal liver metastases (Irresectable Colorectal Liver Metastases, iCRLM). In a clinical study in Norway, 21 patients with iCRLM were enrolled and treated with liver transplantation, although 19 patients had recurrence and metastasis after transplantation (median time 6 months, range 2-24 months). However, the 1-year, 3-year and 5-year survival rates rose to 95%, 68% and 60% after surgery. In this study, the risk factors for poor prognosis after liver transplantation in iCRLM patients were summarized: the largest tumor diameter was more than 5.5 cm, CEA before transplantation was >80ug/ml, the interval between primary disease surgery and transplantation was less than 2 years, and poor response to chemotherapy. Subsequently, the center conducted a second study and performed liver transplantation on 15 patients with iCRLM after optimizing the inclusion criteria. The 1-year, 3-year, and 5-year survival rates were 100%, 83%, and 83%, and the recurrence-free survival rates were 53%, 44%, and 35%. The above studies have proved that liver transplantation can significantly improve the prognosis of patients with iCRLM. However, the shortage of donor livers is the most serious problem faced by iCRLM patients. Moreover, iCRLM is generally considered a contraindication for liver transplantation, so it is more difficult for patients with iCRLM to obtain a donor liver.
Therefore, expanding the donor liver pool is urgently needed for the treatment of patients with iCRLM. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID) . This approach allows transplantation of the left liver (segments 2+3) to an adult recipient, while the remaining enlarged right hemi-liver is transplanted to another adult recipient, effectively avoiding some unsuitable left lateral lobe livers for pediatric recipients to be wasted. Recipients who received right-hemi-liver transplantation had a similar prognosis compared with those who received whole-liver transplantation. Therefore, if the RAPID technique is confirmed to be feasible, it can greatly alleviate the shortage of liver donors. In addition to cadaver sources, living adult donors can also be considered as the source of liver donors. A smaller left lateral lobe donor liver also places less burden on the donor than a left or right hemiliver.
To sum up, our center proposed and designed a clinical study of sequential adult left lateral lobe liver transplantation (SALT) in the treatment of patients with iCRLM based on clinical surgical experience. On the basis of RAPID surgery, the overall survival rate of patients with iCRLM was evaluated by SALT.
- Conditions
- Colon Cancer Liver Metastases
- Being tested
- sequential adult left lateral lobe liver transplantation (SALT)
- Keywords
- liver transplantation, two-stage liver resection, colorectal liver metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential adult left lateral lobe liver transplantation (SALT)Procedure or surgery
Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume. Receives: Procedure: sequential adult left lateral lobe liver transplantation (SALT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival（OS）
To describe overall survival in patients with unresectable colorectal cancer liver metastases treated with sequential adult left lateral lobe liver transplantation.
Measured: 3 years after the second liver resection
Secondary outcomes (1)
Disease-free survival，DFS
Describe the tumor-free survival period of SALT in the treatment of iCRLM
Measured: 1 month, 3 months, 6 months, 1 year, 2 years and 3 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Liver MetastasesStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069960
- Sponsor's protocol ID
- LY2023-186-C
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Adult Left Lateral Lobe Liver Transplantation (SALT) in Patients With Unresectable Colorectal Liver Metastases: a Single-center, Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06069960
- Acronym / sponsor ID
- LY2023-186-C
- Conditions
- Colon Cancer Liver Metastases
- Keywords
- liver transplantation, two-stage liver resection, colorectal liver metastases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Oct 2023 (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.
Colon cancer is a common malignancy with a low survival rate worldwide, and unresectable colon cancer liver metastases (ICRLM) have a worse prognosis. The liver is the most common metastatic organ of colorectal cancer, and palliative chemotherapy is the only option for most ICRLM patients. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%. Liver transplantation is an ideal choice for patients with ICRLM, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of iCRLM. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.
Detailed description
Colorectal cancer is currently the third most common malignant tumor in the world, and about 20%-50% of patients have liver metastases at the time of diagnosis or progress to liver metastases thereafter. The liver is the most frequently invaded organ by colorectal cancer, and liver resection is considered to be the best and only treatment option for patients with colorectal liver metastases (CLMs). However, only about 20% of patients are candidates for radical hepatectomy. For most patients who are not candidates for hepatectomy, palliative chemotherapy is the only option. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%.
Theoretically, liver transplantation is an ideal choice for patients with unresectable colorectal liver metastases (Irresectable Colorectal Liver Metastases, iCRLM). In a clinical study in Norway, 21 patients with iCRLM were enrolled and treated with liver transplantation, although 19 patients had recurrence and metastasis after transplantation (median time 6 months, range 2-24 months). However, the 1-year, 3-year and 5-year survival rates rose to 95%, 68% and 60% after surgery. In this study, the risk factors for poor prognosis after liver transplantation in iCRLM patients were summarized: the largest tumor diameter was more than 5.5 cm, CEA before transplantation was >80ug/ml, the interval between primary disease surgery and transplantation was less than 2 years, and poor response to chemotherapy. Subsequently, the center conducted a second study and performed liver transplantation on 15 patients with iCRLM after optimizing the inclusion criteria. The 1-year, 3-year, and 5-year survival rates were 100%, 83%, and 83%, and the recurrence-free survival rates were 53%, 44%, and 35%. The above studies have proved that liver transplantation can significantly improve the prognosis of patients with iCRLM. However, the shortage of donor livers is the most serious problem faced by iCRLM patients. Moreover, iCRLM is generally considered a contraindication for liver transplantation, so it is more difficult for patients with iCRLM to obtain a donor liver.
Therefore, expanding the donor liver pool is urgently needed for the treatment of patients with iCRLM. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID) . This approach allows transplantation of the left liver (segments 2+3) to an adult recipient, while the remaining enlarged right hemi-liver is transplanted to another adult recipient, effectively avoiding some unsuitable left lateral lobe livers for pediatric recipients to be wasted. Recipients who received right-hemi-liver transplantation had a similar prognosis compared with those who received whole-liver transplantation. Therefore, if the RAPID technique is confirmed to be feasible, it can greatly alleviate the shortage of liver donors. In addition to cadaver sources, living adult donors can also be considered as the source of liver donors. A smaller left lateral lobe donor liver also places less burden on the donor than a left or right hemiliver.
To sum up, our center proposed and designed a clinical study of sequential adult left lateral lobe liver transplantation (SALT) in the treatment of patients with iCRLM based on clinical surgical experience. On the basis of RAPID surgery, the overall survival rate of patients with iCRLM was evaluated by SALT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: sequential adult left lateral lobe liver transplantation (SALT)SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75;
- Physical fitness status (ECOG) 0~1;
- Histologically confirmed primary colorectal neoplasm. The time from primary colorectal tumor resection to transplantation is ≥3 months and the stage of primary colorectal tumor is ≤T3N1. Accept T4N0 or T4N2 if primary tumor resection interval is ≥ 2 years
- Liver metastases (CRLM) located in bilateral livers, or limited to liver and unresectable CRLM after discussion by MDT;
- According to PET/CT, CT and MRI, there are no other abdominal metastases except the liver or 1-3 resectable lung metastases;
Key exclusion criteria (10 listed)
- Extrahepatic tumor burden (except for resectable lung metastases) and/or large vessel tumor infiltration;
- The largest liver tumor lesion >5.5cm at the time of screening;
- Tumor progression during chemotherapy or severe comorbidities that make transplantation impossible;
- BRAF mutation and/or microsatellite instability primary tumor (MSI);
- Suffering from other primary malignant tumors in the past 5 years;
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 |
|---|---|---|
| sequential adult left lateral lobe liver transplantation (SALT)Hemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume. | Procedure or surgery | Surgical group |
Primary outcome
Overall survival（OS）
Time frame: 3 years after the second liver resection
To describe overall survival in patients with unresectable colorectal cancer liver metastases treated with sequential adult left lateral lobe liver transplantation.
1 secondary outcome
Disease-free survival，DFS
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years and 3 years post-transplant
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 6 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Colon Cancer Liver Metastases
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
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sequential adult left lateral lobe liver transplantation (SALT) in people with Colon Cancer Liver Metastases, run by RenJi Hospital.
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 10 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 6 Oct 2023. 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?
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（OS） (time frame: 3 years after the second liver resection). 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 6 Oct 2023.