Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
研究概览
简要总结
RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and <70 years
- •Performance status, ECOG 0-1
- •Histologically proved adenocarcinoma in colon or rectum
- •BRAF wild-type CRC on primary tumor or liver metastases
- •High standard oncological surgical resection of the primary tumor
- •Liver metastases not eligible for curative liver resection confirmed by the validation committee
- •At least one line (3 months) of chemotherapy
- •At least 6 months time span from CRC resection and date of being listed on the transplantation list.
- •At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
- •No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
- •Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3
- •CEA stable or in decrease
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up
排除标准
- •Weight loss >10% the last 6 months
- •Patient BMI > 30
- •Participation refusal
- •General contraindication to LT
- •Other malignancies in the previous 5 years
- •Pregnancy or breast feeding
- •Any reason why, in the opinion of the investigator, the patient should not participate
结局指标
主要结局
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
时间窗: within 4 weeks from liver transplantation
Rate of second stage hepatectomy performed within 4 weeks from transplatation
次要结局
- Mortality(within 90 days from second stage hepatectomy)
- Proportion of drop out(within 100 days from listing)
- Progression free survival(3 and 5 years)
- Intention to treat survival after liver transplantation(3 and 5 years)
- Complication rate(within 90 days after liver transplant)
研究者
Prof. Umberto Cillo
Prof
Azienda Ospedaliera di Padova