Living Donor Liver Transplantation (LDLT) in Non Resectable Colo-rectal Cancer Liver Metastasis. The LIVERMORE Trial (LIVing Donor livEr tRansplant Modena cOloRectal mEtastasis) [Original Title in Italian: "Trapianto di Fegato da Donatore Vivente Per Metastasi Epatiche Non Resecabili da Adenocarcinoma Del Colon"]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM.
Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.
Donor selection is performed according to the currently used Institutional and National standards and protocols.
详细描述
Liver Transplant (LT) is a feasible, safe and effective curative strategy for patients with unresectable colorectal liver metastases (CRLM), and several trials are currently active and in a recruitment phase to study its impact with both conventional donors and living donors (LDLT).
As a matter of fact, in this setting living donors represent a helpful resource, thanks to the opportunity to schedule the LT at the timeliest conditions in terms of oncological response and patient's performance status. LDLT is a well-established procedure that is already offered to patients listed for LT at our Institution.
Crucial requirement for study eligibility is the assessment of non-resectability of the presented liver metastases from colorectal cancer (CRC).
Criteria for non-resectability of the liver-only CRC metastases eligible for the study should be assessed at the patient study entry, by the surgeon in charge together with the multidisciplinary team.
Patients fulfilling the inclusion criteria of the study will undergo clinical, translational and regulatory steps. Briefly, the main procedures and requirements of the study can be summarized as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
- •Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component >50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.
- •No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.
- •Liver metastases not eligible for curative liver resection
- •Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete [CR] or partial response [PR] or standard disease [SD]) during second- line treatment for at least 4 months.
- •Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.
- •Performance status, ECOG (Eastern Cooperative Oncology Group) 0-
- •Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations.
排除标准
- •Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
- •Prior extra hepatic metastatic disease or primary tumor local relapse.
- •Palliative resection of primary CRC tumor.
- •Disease progression
- •Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).
- •Active intra-venous or alcohol abusers (patients may be eligible if abstention > 6 months is demonstrated)
- •Active HIV infection
- •Psychiatric disorders and patient low compliance
- •Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)
结局指标
主要结局
Overall survival
时间窗: 5 years
Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only
Disease free survival
时间窗: 5 years
Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only
次要结局
- Donor quality of life(5 years)
- Graft survival(5 years)
研究者
Fabrizio Di Benedetto
Professor
Azienda Ospedaliero-Universitaria di Modena