Liver transplantation for patients with advanced bile duct cancer after treatment
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)
This study is testing if liver transplantation can help patients with advanced bile duct cancer who have managed to control their tumors with treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy, durvalumab |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT06862934 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of liver transplantation in patients with unresectable intrahepatic cholangiocarcinoma who have achieved sustained tumor control through a combination of chemotherapy, immunotherapy, and transarterial radioembolization. Patients will undergo a series of imaging tests and treatments to downstage their cancer before being evaluated for transplantation eligibility. The study aims to determine if successful downstaging can lead to better outcomes post-transplantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with biopsy-proven unresectable intrahepatic cholangiocarcinoma who have achieved disease stability for at least 6 months.
Not a fit: Patients with macrovascular invasion, extrahepatic spread, or those who cannot undergo the necessary treatments due to medical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced bile duct cancer, potentially improving survival rates.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using liver transplantation for other liver cancers after downstaging, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological diagnosis of iCCA (biopsy-proven tumor) * Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection) * Unresectability assessment due to tumor location (leading to insufficient live remnant with/out implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan). * Age between 18 and 70 years * No macrovascular tumor invasion (NB: portal vein and/or hepatic vein occlusion from the external tumor compression and classified as "encasement" could be considered after expert radiology review) * No extrahepatic spread * Disease stability for at least 6 months * CA 19-9 \< 200 u/ml at transplant listing in absence of jaundice * No medical and surgical contraindications to liver transplantation * Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1 * No concomitant malignancies or history of other malignancies in the previous 5 years * Written informed consent Exclusion Criteria: * Hilar and distal cholangiocarcinoma * Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria * Evidence of lymph-nodal metastases * Evidence of extrahepatic disease * Prior extrahepatic metastatic disease * Concomitant malignancies or history of other malignancies in the previous 5 years * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * Any reason why, in the opinion of the investigator, the patient should not participate to the study
Where this trial is running
Milan, Milan
- Fondazione IRCCS Istituto Nazionale Tumori di Milano — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Vincenzo Mazzaferro, MD, PhD
- Email: vincenzo.mazzaferro@istitutotumori.mi.it
- Phone: 0223902760
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.