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

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.

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Key information

Conditions

Liver Transplant Disorder Digestive System Diseases Digestive System Neoplasms End Stage Liver Disease End-Stage Liver DIsease Hepatic Cancer Hepatic Insufficiency Liver Diseases Liver Failure Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

assisted liver transplantation combined with two-stage hepatectomy

Procedure

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

Primary outcomes

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.

Secondary outcomes

Postoperative tumor-free survival period

Time frame: 3 years after the second liver resection

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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Zhengzhou University

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Mar 1, 2023
Registry last updated: Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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