Liver transplant with chemo-radiotherapy for unresectable hilar cholangiocarcinoma
Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. A Prospective Multicenter Study.
Hospital Vall d'Hebron · NCT04378023
This study is testing if liver transplants combined with chemotherapy and radiation can help younger patients with inoperable hilar cholangiocarcinoma live longer and stay cancer-free.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospital Vall d'Hebron (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04378023 on ClinicalTrials.gov |
What this trial studies
This multicenter study aims to evaluate the effectiveness of liver transplantation combined with neoadjuvant chemo-radiotherapy in patients diagnosed with unresectable hilar cholangiocarcinoma. Patients aged 70 or younger with tumors ≤3cm and no evidence of metastases will be included. The primary endpoint is overall survival at 1, 3, and 5 years post-transplant, while secondary endpoints include recurrence-free survival and the rate of patients who undergo transplantation. The study will involve comprehensive radiological evaluations to confirm eligibility.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 or younger with unresectable hilar cholangiocarcinoma ≤3cm in diameter and no evidence of metastases.
Not a fit: Patients with prior chemotherapy or radiotherapy, metastases, or other concurrent cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with unresectable hilar cholangiocarcinoma.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with unresectable cancers through combined therapies.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Barcelona
- Department of HPB Surgery and Transplants, Hospital Vall d´Hebron — Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Cristina Dopazo — HOSPITAL UNIVERSITARIO VALL D´HEBRON, UNIVERSIDAD AUTONOMA, BARCELONA
- Study coordinator: CRISTINA DOPAZO, MD/PhD
- Email: cristina.dopazo@vallhebron.cat
- Phone: +34932746113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unresectable Cholangiocarcinoma