Liver transplantation for patients with unresectable perihilar 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

LITALHICA is a prospective non-randomized study that investigates the outcomes of liver transplantation in patients diagnosed with unresectable perihilar cholangiocarcinoma after receiving standard chemotherapy. The study aims to evaluate overall survival and quality of life post-transplant, while also identifying biological markers and clinical factors that predict better outcomes. Additionally, it explores the utility of preoperative PET-MRI imaging in assessing lymph node involvement, correlating these findings with histological results following lymphadenectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of pCCA (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, or biliary ploidy with a malignant appearing stricture on cholangiography)
* Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes
* No extrahepatic metastatic disease
* Radial tumor diameter ≤3 cm
* At least six months between first diagnosis of pCCA and date of inclusion
* At least six months of SOC chemotherapy, achieving disease stability or partial response

Exclusion Criteria:

* Uncontrollable infection
* Prior radiotherapy or chemotherapy
* Prior biliary surgical resection or attempted surgical resection
* Diameter of tumor \>3cm
* Presence of intra-hepatic metastases or iCCA
* Present or past evidence of extrahepatic metastatic disease
* Transperitoneal biopsy (including percutaneous ecography-guided FNA)
* Prior neoplasms, except those treated curatively for more than 5 years without recurrence
* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study
* Pregnant or breastfeeding women
* Medical-surgical contraindications for liver transplantation

Where it's running

• Azienda Ospedale Università di Padova
  Padova, Padova, Italy Recruiting

Study contacts

• Principal investigator: Enrico Gringeri, Prof. — Azienda Ospedale Università di Padova
• Study coordinator: Enrico Gringeri, Prof.
• Email: enrico.gringeri@unipd.it
• Phone: +39 0498218547

Similar studies

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

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• Robot-assisted surgery for perihilar cholangiocarcinoma

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• Using PD-1 antibody and GEMOX for treating perihilar cholangiocarcinoma after surgery

  This study is testing if a combination of a PD-1 antibody and GEMOX chemotherapy can help patients with perihilar cholangiocarcinoma who have had surgery and have cancer in their lymph nodes live longer and feel better.

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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.