Liver Transplantation With Two-stage Liver Resection in Unresectable Liver Cancer , Metastases or Emd-stage Liver Disease (LTLR-LC)

Liver Transplant Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750329
• Other study ID #: Renji-LT-2022-0001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. aged 18-75 years;

2. 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;

3. patients with end-stage liver disease;

4. preoperative Child classification of A or B, able to tolerate the subsequent surgical program

5. 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

Exclusion Criteria:

1. Extrahepatic tumor burden (except for resectable lung metastases) and/or macrovascular tumor infiltration

2. Tumor progression during chemotherapy or important comorbidities that affect surgery

3. Uncorrectable cardiopulmonary disease with high surgical risk

4. Anatomical abnormalities that preclude liver transplantation

5. Persistent non-compliance with medical care

6. Combined with other diseases such as AIDS that affect surgery or tumor progression

Related Conditions & MeSH terms

• End Stage Liver Disease
• End-stage Liver Disease
• Hepatic Cancer
• Liver Diseases
• Liver Neoplasms
• Liver Transplant Disorder

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years after the second liver resection
Secondary	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.	3 years after the second liver resection