Status:
RECRUITING
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Lead Sponsor:
Azienda Sanitaria Ospedaliera
Collaborating Sponsors:
Istituto Oncologico Veneto IRCCS
Conditions:
Perihilar Cholangiocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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)
- Disease considered unsuitable for hepatic resection based on tumor location and extent or underlying liver dysfunction
- Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes detected on radiological study
- No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and PET-MR (or PET-CT)
- Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
- Radial tumor diameter \<3 cm
- At least six months have passed since the first diagnosis of pCCA to the date of inclusion on the liver transplant waiting list
- The patient has received at least six months of standard of care (SOC) chemotherapy, achieving disease stability or partial response (according to RECIST criteria version 1.1) at the time of listing for transplantation
- Absence of medical or surgical contraindication to liver transplantation
- Signed informed consent, and expected patient cooperation for treatment and follow-up, must be obtained and documented according to good clinical practice and national/local regulations
Exclusion
- Diagnosis of intrahepatic cholangiocarcinoma (iCCA)
- Uncontrollable infection
- Prior radiotherapy or chemotherapy
- Prior biliary surgical resection or attempted surgical resection
- Diameter of tumor \>3cm
- Presence of intra-hepatic metastases
- 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 or with the evaluation of study outcomes
- Pregnant or breastfeeding women
- Medical-surgical contraindications for liver transplantation
- Any reason for which, in the investigator's judgment, the patient should not participate in the study
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2033
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06125769
Start Date
January 15 2024
End Date
November 1 2033
Last Update
January 24 2024
Active Locations (1)
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1
Azienda Ospedale Università di Padova
Padua, Italy, 35128