Liver transplantation for patients with advanced bile duct cancer

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 observational study investigates the effectiveness of liver transplantation in patients with unresectable perihilar cholangiocarcinoma who have achieved disease control through a combination of chemotherapy, immunotherapy, and stereotactic body radiation therapy. Eligible patients will undergo a series of treatments aimed at downstaging their cancer before being evaluated for liver transplantation. The study involves careful monitoring and restaging of the disease to ensure stability before transplantation. The goal is to determine if liver transplantation can be a viable option for these patients after successful treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
* Transcatheter biopsy or brush cytology
* CA-19.9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
* Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
* Age between 18 years and 70 years
* Absence of intra- and extrahepatic metastases
* Absence of lymph-nodal metastases at any site
* Biliary stenting of all liver districts
* No contraindications to liver transplantation
* No concomitant malignancies or history of other malignancies in the previous 5 years
* Written informed consent

Exclusion Criteria:

* Intrahepatic cholangiocarcinoma
* Uncontrolled infection
* Concomitant malignancies or history of other malignancies in the previous 5 years

Where it's running

• Fondazione IRCCS Istituto Nazionale Tumori di Milano
  Milan, Michigan, Italy Recruiting

Study contacts

• Study coordinator: Vincenzo Mazzaferro, MD, PhD
• Email: vincenzo.mazzaferro@istitutotumori.mi.it
• Phone: 0223902760

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Liver transplantation for patients with inoperable bile duct cancer

  This study is testing if liver transplantation can help people with inoperable bile duct cancer live longer and have a better quality of life.

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• Preoperative Lymph Node Assessment in Cholangiocarcinoma using Endoscopic Ultrasound

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• Using Raman Spectroscopy to Diagnose Extrahepatic Cholangiocarcinoma

  This study is testing a new way to diagnose extrahepatic cholangiocarcinoma using a special light technique during a procedure to see if it can better identify cancer in the bile ducts.

  Recruiting University Hospital Olomouc · Olomouc, Olomouc Region · NCT06964425

• Neoadjuvant gemcitabine and cisplatin with perioperative pembrolizumab vs upfront surgery for cancers of the bile ducts

  This trial tests whether giving chemotherapy with pembrolizumab before surgery helps people with resectable or borderline resectable extrahepatic cholangiocarcinoma see if they have better outcomes than going straight to surgery.

  Recruiting Phase 2/3 Amsterdam UMC, location VUmc · Amsterdam · NCT06923475

• Robot-assisted surgery for perihilar cholangiocarcinoma

  This study is testing if robot-assisted surgery can help patients with perihilar cholangiocarcinoma remove their tumors safely and recover better than with traditional surgery.

  Recruiting Azienda Ospedaliera di Padova · Padova · NCT06720883

• Using radiation therapy after chemotherapy for inoperable bile duct cancer

  This study is testing if adding a special type of radiation therapy after chemotherapy can help people with inoperable bile duct cancer live longer and feel better.

  Recruiting at 6 sites Erasmus Medical Center · Wilrijk, Antwerp and 7 other locations · NCT06493734

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.