Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Che… (NCT01549795) | Clinical Trial Compass
UnknownNot Applicable
Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy
Italy33 participantsStarted 2012-01
Plain-language summary
Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.
Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.
New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Older than 18 years
* Male or female
* Diagnosis of Cholangiocarcinoma using:
* PTBD biopsy or Brushing cytology
* Ca 19-9\>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
* Non resectable tumour araising above the cystic duct
* Absence of intra and extra hepatic metastasis
* ECOG score(Eastern Cooperative Oncology Group) 0
* ASA score (American Society of Anesthesiologists) ≤ 3
* Ability to understand and willingness to sign the written informed consent form (ICF)
Exclusion Criteria:
* Intrahepatic Cholangiocarcinoma
* Non controlled infection
* Previous radio or chemotherapy
* Previsous bile duct resection or attempt to resection
* Intra and/or extrahepatic metastasis
* Preivious malignant neoplasm (within 5 years)
* Execution of trans peritoneal biopsy
* Tumour diameter more than 3 cm
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses neoadjuvant radiation and chemotherapy before a liver transplant for hilar cholangiocarcinoma — is that combination approach something you'd consider appropriate for my specific situation, and how does it compare to other treatment paths available to me?
2The trial is measuring how many patients are disease-free at 24 months after transplant and how long it takes for cancer to come back — based on what's already known from similar protocols, what kind of outcomes should I realistically expect?
3Since the recruitment status for this trial is listed as unknown, is it actually still enrolling patients, and if not, are there similar active trials or centers following this same neoadjuvant plus transplant protocol that I could be referred to?
4I have hilar cholangiocarcinoma and the trial also includes people with primary sclerosing cholangitis — does it matter for my eligibility or prognosis whether my cancer developed from PSC or not, and how does that affect which approach my care team would recommend?
5Going through chemotherapy and radiation before a major transplant surgery is a significant physical and logistical burden — given my current health and support situation, is my body likely to tolerate the full neoadjuvant treatment course well enough to even reach the transplant stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients free of disease at 24 months post-transplant