This Study Will Investigate Whether En Bloc Resection of the Liver and Pancreas with a "non-touch" Technique Followed by Liver Transplantation Will Improve the Overall Survival in Patients with Non-resectable Hilar Cholangiocarcinoma Beyond the Mayo Clinic Transplant Criteria

Launched by OSLO UNIVERSITY HOSPITAL · Feb 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical approach for patients with a type of liver cancer called hilar cholangiocarcinoma, which is often difficult to treat and may not be removable by traditional surgery. The goal is to see if a special technique called "en bloc resection," where the liver, pancreas, and other nearby organs are removed together, can help these patients. This approach aims to ensure that the cancer is completely removed by taking a larger area around the tumor, which may lead to better outcomes compared to standard treatments. The trial will include patients who have been diagnosed with this cancer but are not eligible for standard liver transplantation due to the extent of the disease.

To participate in the trial, patients must have a confirmed diagnosis of hilar cholangiocarcinoma and meet specific criteria, such as having no distant spread of the cancer. They should also have undergone chemotherapy and radiation therapy for at least six months before joining the study. Participants can expect to undergo the new surgical procedure, followed by a liver transplant if suitable. The main focus of the trial is to see how long patients survive after treatment, with follow-up assessments at one, three, and five years. Overall, this trial represents a hopeful option for patients facing challenging circumstances due to this aggressive cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 \> 100U/L
• • Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in PSC patients more than 24 months following the previous resection (N0, R0, no macrovascular involvement) is accepted.
• • Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.
• • Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.
• • No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)
• • Good performance status Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
• • At least 6 months of observation time during which the patient should be treated by chemotherapy and radiation (hyperfractioned 30-50 Gy) with response or stable disease before listing for LT. Patients with PSC and significant liver dysfunction that restricts the tolerability of chemoradiotherapy may be considered on an individual basis
• Exclusion Criteria:
• • Radiological signs of tumor invasion along intended resection borders
• • Direct tumor invasion of the pancreatic head
• • Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes
• • Perforation of the visceral peritoneum
• • Weight loss \>10% in the last six months
• • Patient BMI \> 30 kg/m2
• • Other malignancies, except curatively treated basal cell carcinoma or other tumors with disease-free interval \> five years without relapse. The final decision on acceptable previous cancer diagnoses is at the principal investigator's discretion.
• • Known history of human immunodeficiency virus (HIV) infection
• • Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• • Known hypersensitivity to rapamycin
• • Prior metastatic disease
• • Women who are pregnant or breastfeeding
• • Any reason why, in the opinion of the investigator, the patient should not participate