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New treatment option for Perihilar Cholangiocarcinoma
Official title LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
ClinicalTrials.gov ID: NCT06125769
What this study is testing
- What it's testing
- LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Padova, PADOVA, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Padova, PADOVA, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.