Liver transplantation for patients with unresectable perihilar cholangiocarcinoma
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
This study is testing if liver transplantation can help people with a specific type of cancer that can't be surgically removed feel better and live longer after they’ve had standard chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Azienda Sanitaria Ospedaliera Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova, PADOVA) |
| Trial ID | NCT06125769 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with unresectable perihilar cholangiocarcinoma who have undergone at least six months of standard chemotherapy.
Not a fit: Patients with evidence of extrahepatic metastatic disease or major vascular invasion will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with unresectable perihilar cholangiocarcinoma, potentially improving survival rates and quality of life.
How similar studies have performed: While liver transplantation for cholangiocarcinoma is a novel approach, similar studies have shown promising results in selected patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Padova, PADOVA
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.