Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
Hospital Vall d'Hebron
34 participants
Apr 24, 2020
OBSERVATIONAL
Conditions
Summary
A prospective multicentre study which includes patients ≤ 70 years-old diagnosed of unresectable hilar cholangiocarcinoma (hCCA) ≤3cm in radial diameter, without evidence of lymph node or distant metastases. Liver transplantation preceded by neoadjuvant radio-chemotherapy 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 overall patients included in the study at 1,3 and 5 year; 3) the rate of patients included in the study who are finally transplanted.
Eligibility
Inclusion Criteria4
- Willing and able to provide written consent form
- Age ≤ 70 years-old
- ECOG 0 or 1
- Unresectable hCCA ≤3cm in radial diameter
Exclusion Criteria5
- 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
Interventions
Patients will receive neoadjuvant radiotherapy (External - 50-54 grays) following by concomitant oral capecitabine (825mg/m2 bid).Thereafter, gemcitabine iv (1000mg/m2) plus cisplatin iv (25mg/m2) will be administered the day 1 and 8 every 21 days until transplant.
If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04378023