Liver Transplant with Chemo-Radiotherapy for Cholangiocarcinoma
Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Perihilar Cholangiocarcinoma. A Prospective Multicenter Study.
Recruiting
Observational Study
Unresectable Cholangiocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Observational
Participants needed
34 (estimated)
Sponsor
Hospital Vall d'Hebron · Other
Who this trial is looking for
This trial is looking for patients under 70 years old with unresectable perihilar cholangiocarcinoma that is 3cm or smaller. Participants will receive neoadjuvant chemo-radiotherapy followed by liver transplantation.
Are You a Good Fit for This Trial?
You may be able to join if
I am under 70 years old
I have been diagnosed with unresectable perihilar cholangiocarcinoma
My cancer is 3cm or smaller in size
I can provide written consent
My ECOG score is 0 or 1
You may not be able to join if
I have received chemotherapy or radiotherapy outside of this trial
I have liver, extrahepatic, or lymph node metastases
I have had previous surgery planned for my cancer
I have a different cancer that is not adenocarcinoma, except for certain treated cancers
I have an uncontrolled infection
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.
The primary endpoint will be overall survival at 1, 3, and 5 years post-transplan…
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable perihilar cholangiocarcinoma (pCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radiochemotherapy will be performed in this selected group.
The primary endpoint will be overall survival at 1, 3, and 5 years post-transplant. The secondary endpoints will be: 1) recurrence-free survival at 1, 3 and 5 years post-transplant; 2) intention-to-treat survival of all patients included in the study at 1,3 and 5 years; 3) the rate of patients included in the study who are finally transplanted.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Willing and able to provide written consent form
* Age ≤ 70 years-old
* ECOG 0 or 1
* Unresectable hCCA ≤3cm in radial diameter
Exclusion Criteria:
* Those patients who have received chemotherapy or radiotherapy previously out of protocol
* Liver, extrahepatic or lymph node …
Inclusion Criteria:
* Willing and able to provide written consent form
* Age ≤ 70 years-old
* ECOG 0 or 1
* Unresectable hCCA ≤3cm in radial diameter
Exclusion Criteria:
* Those patients who have received chemotherapy or radiotherapy previously out of protocol
* Liver, extrahepatic or lymph node metastases
* Previous intent of surgical resection or percutaneous biopsy
* Previous or concurrent cancer that is different in primary site or histology from adenocarcinoma, except cervical carcinoma in situ, localized prostate cancer, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated 5 years prior to entry is permitted.
* Infection no controlled
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