Liver Transplant DisorderNCT05750329
Liver Transplantation With Two-stage Liver Resection in Unresectable Liver Cancer , Metastases or Emd-stage Liver Disease (LTLR-LC)
A study testing assisted liver transplantation combined with two-stage hepatectomy in people with Liver Transplant Disorder and Hepatic Cancer, run by RenJi Hospital.
Trial summary
Colon cancer and primary liver cancer are common malignant tumors with low survival rate worldwide, and unresectable primary liver cancer and colon cancer liver metastases have worse prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplant Disorder, Hepatic Cancer, End-stage Liver Disease
- What is being tested?
- assisted liver transplantation combined with two-stage hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-75 years;
- patients with unresectable primary hepatocellular carcinoma or colorectal cancer with liver metastases who also meet the following criteria: tumor shrinkage (still unresectable) or no significant progression after a first-line chemotherapy regimen of 6-8 weeks; no other abdominal metastases or 1-3 resectable pulmonary metastases;
- patients with end-stage liver disease;
- preoperative Child classification of A or B, able to tolerate the subsequent surgical program
- Signed informed consent Note: One of the second or third criteria needs to be fulfilled and all the rest of the selection criteria need to be fulfilled
Who cannot join
- Extrahepatic tumor burden (except for resectable lung metastases) and/or macrovascular tumor infiltration
- Tumor progression during chemotherapy or important comorbidities that affect surgery
- Uncorrectable cardiopulmonary disease with high surgical risk
- Anatomical abnormalities that preclude liver transplantation
- Persistent non-compliance with medical care
- Combined with other diseases such as AIDS that affect surgery or tumor progression
About this study
Official title: Clinical Study of Adjuvant Liver Transplantation Combined With Two-stage Hepatectomy for the Treatment of Patients With Unresectable Primary Hepatocellular Carcinoma, Colorectal Cancer With Liver Metastases, or End-stage Liver Disease: a Multicenter, Prospective, Single-arm Study
Colon cancer and primary liver cancer are common malignant tumors with low survival rate worldwide, and unresectable primary liver cancer and colon cancer liver metastases have worse prognosis. End-stage liver disease is equated with advanced liver disease, liver failure and decompensated cirrhosis because they are generally irreversible. Liver transplantation is a treatment option for the above-mentioned patients and is expected to improve the prognosis of the patients, but the biggest problem faced by such patients is the shortage of donor livers. Recently, a new surgical modality, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID), can greatly alleviate these problems.Based on clinical surgical experience, our center proposes and designs a clinical study of adjuvant liver transplantation combined with two-stage hepatectomy in the treatment of patients with unresectable primary liver cancer, colorectal cancer liver metastases, or end-stage liver disease. By improvement of RAPID operation, the safety and efficacy of this treatment method in patients with those disease were evaluated.
- Being tested
- assisted liver transplantation combined with two-stage hepatectomy
- Keywords
- liver transplantation, Hepatectomy
- Medical subject headings
- Liver Neoplasms, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assisted liver transplantation combined with two-stage hepatectomyProcedure or surgery
Stage 1 Surgery: Left Hepatectomy, Left Lateral Graft Implantation, Portal Shunt to Graft Intermediate stage: continuous monitoring of liver function indexes and liver transplant donor volume after the first stage of surgery. Until the graft size reaches 0.8% of body weight (GBWR), or 35%-45% of the standard liver volume.
Stage 2 Surgery: Residual Right Hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Experimental | All patients underwent left hepatectomy combined with orthotopic S2-3 liver segment transplantation, and then underwent autologous right hepatectomy after the graft had grown sufficiently large. Receives: Procedure: assisted liver transplantation combined with two-stage hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year overall survival rate after surgery
After the second liver resection, patients were followed up through outpatient clinics and telephone (interval: once a month for a total of three years). The end point of follow-up was the death of the patient or survival after three years of follow-up. After reaching the end point of follow-up, the overall survival rate was analyzed by drawing survival curves.
Measured: 3 years after the second liver resection
Secondary outcomes (1)
Postoperative tumor-free survival period
After the second liver resection, regular follow-up of patients' serological and imaging indicators: Serological indicators include tumor markers, such as AFP, AFP heterogeneity, CEA, CA19-9, etc., imaging Medical indicators include abdominal ultrasound, enhanced CT, enhanced magnetic resonance or PET-CT examination. Serological examination and B-ultrasound examination should be performed once a month for the first year after surgery, and once every three months for the next two years. Enhanced CT or enhanced MRI should be performed at the 1st, 3rd, and 6th months after operation, and then once every six months (if the serology or B-ultrasound examination indicates abnormalities, an additional examination will be performed). Two or more imaging examinations diagnosed as malignant tumors were considered as tumor recurrence. Tumor recurrence or no recurrence after three years of follow-up was used as the end point of the study.
Measured: 3 years after the second liver resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startAug 2023 (estimated)
- Primary completionAug 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 Liver Transplant DisorderStudies 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
- All enrolled patients received assisted liver transplantation combined with two-stage hepatectomy Stage 1 Surgery: Left Hepatectomy, Left Lateral Graft Implantation, Portal Shunt to Graft Intermediate stage: continuous monitoring of liver function indexes and liver transplant donor volume after the first stage of surgery. Until the graft size reaches 0.8% of body weight (GBWR), or 35%-45% of the standard liver volume. Stage 2 Surgery: Residual Right Hepatectomy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750329
- Sponsor's protocol ID
- Renji-LT-2022-0001
- Status last verified
- Aug 2023
- First submitted
- 4 Jan 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Adjuvant Liver Transplantation Combined With Two-stage Hepatectomy for the Treatment of Patients With Unresectable Primary Hepatocellular Carcinoma, Colorectal Cancer With Liver Metastases, or End-stage Liver Disease: a Multicenter, Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT05750329
- Acronym / sponsor ID
- Renji-LT-2022-0001
- Keywords
- liver transplantation, Hepatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Mar 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 and primary liver cancer are common malignant tumors with low survival rate worldwide, and unresectable primary liver cancer and colon cancer liver metastases have worse prognosis. End-stage liver disease is equated with advanced liver disease, liver failure and decompensated cirrhosis because they are generally irreversible. Liver transplantation is a treatment option for the above-mentioned patients and is expected to improve the prognosis of the patients, but the biggest problem faced by such patients is the shortage of donor livers. Recently, a new surgical modality, resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID), can greatly alleviate these problems.Based on clinical surgical experience, our center proposes and designs a clinical study of adjuvant liver transplantation combined with two-stage hepatectomy in the treatment of patients with unresectable primary liver cancer, colorectal cancer liver metastases, or end-stage liver disease. By improvement of RAPID operation, the safety and efficacy of this treatment method in patients with those disease were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled patients received assisted liver transplantation combined with two-stage hepatectomy Stage 1 Surgery: Left Hepatectomy, Left Lateral Graft Implantation, Portal Shunt to Graft Intermediate stage: continuous monitoring of liver function indexes and liver transplant donor volume after the first stage of surgery. Until the graft size reaches 0.8% of body weight (GBWR), or 35%-45% of the standard liver volume. Stage 2 Surgery: Residual Right Hepatectomy
| Arm | Type | Receives |
|---|---|---|
| Surgical group | Experimental | Procedure: assisted liver transplantation combined with two-stage hepatectomyAll patients underwent left hepatectomy combined with orthotopic S2-3 liver segment transplantation, and then underwent autologous right hepatectomy after the graft had grown sufficiently large. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18-75 years;
- patients with unresectable primary hepatocellular carcinoma or colorectal cancer with liver metastases who also meet the following criteria: tumor shrinkage (still unresectable) or no significant progression after a first-line chemotherapy regimen of 6-8 weeks; no other abdominal metastases or 1-3 resectable pulmonary metastases;
- patients with end-stage liver disease;
- preoperative Child classification of A or B, able to tolerate the subsequent surgical program
- Signed informed consent Note: One of the second or third criteria needs to be fulfilled and all the rest of the selection criteria need to be fulfilled
Key exclusion criteria (6 listed)
- Extrahepatic tumor burden (except for resectable lung metastases) and/or macrovascular tumor infiltration
- Tumor progression during chemotherapy or important comorbidities that affect surgery
- Uncorrectable cardiopulmonary disease with high surgical risk
- Anatomical abnormalities that preclude liver transplantation
- Persistent non-compliance with medical care
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 |
|---|---|---|
| assisted liver transplantation combined with two-stage hepatectomyStage 1 Surgery: Left Hepatectomy, Left Lateral Graft Implantation, Portal Shunt to Graft Intermediate stage: continuous monitoring of liver function indexes and liver transplant donor volume after the first stage of surgery. Until the graft size reaches 0.8% of body weight (GBWR), or 35%-45% of the standard liver volume. Stage 2 Surgery: Residual Right Hepatectomy | Procedure or surgery | Surgical group |
Primary outcome
Three-year overall survival rate after surgery
Time frame: 3 years after the second liver resection
After the second liver resection, patients were followed up through outpatient clinics and telephone (interval: once a month for a total of three years). The end point of follow-up was the death of the patient or survival after three years of follow-up. After reaching the end point of follow-up, the overall survival rate was analyzed by drawing survival curves.
1 secondary outcome
Postoperative tumor-free survival period
Time frame: 3 years after the second liver resection
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 7 Aug 2023.
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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.
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 assisted liver transplantation combined with two-stage hepatectomy in people with Liver Transplant Disorder and Hepatic Cancer, 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 5 inclusion and 6 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 7 Aug 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?
Three-year overall survival rate after surgery (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 7 Aug 2023.