Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
-
- STATUS
- Recruiting
-
- days left to enroll
- 50
-
- participants needed
- 34
-
- sponsor
- Hospital Vall d'Hebron
Summary
A prospective multicentre pilot study which includes patients 70 years-old diagnosed of
unresectable
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 overall patients included in the study at 1,3 and 5 year;
3) the rate of patients included in the study who are finally
Description
A prospective multicentre pilot study which includes patients 70 years-old diagnosed of
unresectable
The number of subjects necessary is 34 patients to achieve a power of 82% with a significance
level of 0.05 to detect a 40% difference between the estimated 50% survival of those patients
who are
RADIOLOGICAL
It will be considered unresectable those lesions
- Bilateral extension to second order biliary
- Unilateral extension to second-order biliary radicals AND contralateral portal vein
involvement OR contralateral hepatic
lobar atrophy - Main or bilateral portal vein involvement
- Insufficient future
liver remnant even after portal embolization
It will be performed the tumoral marker (CA 19.9), multiphase chest-abdomen
NEOADJUVANT TREATMENT
Patients will receive neoadjuvant
A staging
A score exception will be allowed to optimized the treatment received and to be
Regarding
The patient will be monitored post-operatively at the clinical, biological and morphological levels every 3 months during the first 2 years and every 6 months thereafter in order to detect any recurrence and in the context of standard clinical care.
Details
| Condition |
Unresectable |
|---|---|
| Age | 18years - 70years |
| Treatment |
Neoadjuvant Chemo-radiotherapy,
|
| Clinical Study Identifier | NCT04378023 |
| Sponsor | Hospital Vall d'Hebron |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.