DRKS00017730尚未招募未知
Partial liver Segment 2/3 Transplantation with delayed total hepatectomy as treatment for selected Patients with Liver Metastases from Colorectal Carcinoma - RAPID-MUC
Klinik für Allgemein-, Viszeral-, und Transplantationschirurgie, Klinikum der Universität München0 个研究点目标入组 20 人开始时间: 2019年9月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
- •2. Primary Colorectal cancer tumor stage is =T4a
- •3. Primary tumor removed with adequate (R0) resection margins, including circumferential resection margins (CRM) of at least =2mm for rectal cancer patients.
- •4. Time from primary CRC resection to transplant is =6 months
- •5. Bilateral and non-resectable LM
- •6. No major vascular invasion by LM; metastases isolated to liver
- •7. The patient has undergone first-line systemic chemotherapy (doublet/triplet +/- bevacizumab or doublet/triplet +/- anti-EGFR moAb) for =8 weeks
- •8. Demonstrated stability or regression of LM, according to RECIST-criteria, over at minimum the 3 months preceding the screening
- •9. Carcinoembryonic Antigen (CEA) values are stable or decreasing at all time points before the transplant surgery.
- •10. No signs of extrahepatic metastatic disease or local recurrence according to PET/CT scan within 12 weeks before deceased donor partial liver transplantation, and 4 weeks before living donation
- •11. No signs of extrahepatic metastatic disease on CT thorax/abdomen/pelvis within 12 weeks before deceased donor partial liver transplantation, and 4 weeks prior to living donation.
- •12. No local recurrence according to MR-pelvis scan in patients with rectal cancer within 12 weeks before deceased donor partial liver transplantation, and 4 weeks before living donation
- •13. No signs of local recurrence judged by colonoscopy within 12 months prior transplantation
- •14. Good performance status, ECOG 0 or 1.
- •15. Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, ASAT,ALAT<5 x upper normal level, Creatinine <1.25 x upper normal level. Albumin above the lower normal level. Thrombocyte count > 100
排除标准
- •1. Previous or concurrent cancer (with some exceptions)
- •2. Prior liver resection (performed with curative intent) where current LM represents recurrent disease
- •3. Extrahepatic/metastatic disease
- •4. BRAF-V600 mutation as a predictor of very poor prognosis
- •5. Microsatellite instability (MSI) or mismatch repair deficiency (MMRd) that can be treated by check-point inhibition
- •6. CEA > 80 ng/ml at baseline
- •7. Any confirmed rise of CEA during chemotherapy
- •8. Weight loss >10% during the last three months
- •9. Any condition that is unstable or which could jeopardize the safety of the patient
研究者
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