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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Three-year overall survival rate after surgery [Срок оценки: 3 years after the second liver resection]

Вторичные конечные точки (1)

• Postoperative tumor-free survival period [Срок оценки: 3 years after the second liver resection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05750329 · Renji-LT-2022-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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