Investigating liver and pancreas surgery followed by transplantation for advanced cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of en bloc resection of the liver and pancreas using a 'non-touch' technique, followed by liver transplantation, in improving overall survival for patients with non-resectable hilar cholangiocarcinoma. The study focuses on patients who do not meet the Mayo Clinic's criteria for transplantation and assesses the potential benefits of this aggressive surgical approach. The trial will include patients with histologically verified cholangiocarcinoma and will monitor their outcomes post-surgery. The goal is to determine if this method can provide better survival rates compared to current treatment options.

Why it matters

Who can join: the full rules

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

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Study coordinator: Pål-Dag Line, MD PhD
• Email: paaldl@uio.no
• Phone: 23070509

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.