- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195503
Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma
Liver Transplantation in Locally- Advanced, Unresectable, Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy: A Single-centre, Pilot Study
Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is an increasingly common form of primary liver cancer, but patients with this diagnosis are not currently eligible for LT. This study proposes to offer LT as an option to patients with advanced, unresectable iCCA who demonstrate at least 6 months of disease stability /regression while receiving standard chemotherapy. Patients will be referred and screened for study participation if they have achieved 6 months of disease stability.
They will be worked up for transplant and if eligible, will be listed. Disease must remain controlled while awaiting transplantation. After transplantation, patients will be followed for disease recurrence and overall survival, while receiving standard post-transplantation followup.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients treated with standard of care chemotherapy for unresectable, biopsy-proven intrahepatic cholangiocarcinoma, and who demonstrate stability/regression of disease for a minimum of 6 months, may be eligible for study. Following informed consent and screening, eligible patients with a potential live liver donor (an interested, ABO-compatible individual, without obvious contraindications for donation) will be evaluated for transplantation. During this period, patients will continue to receive chemotherapy and imaging at the usual intervals. Once a patient completes the pre-transplant assessments and is deemed "suitable for transplantation" , the living donor's assessments may begin. If the donor is found suitable, a tentative date will be set for the surgeries. Systemic chemotherapy will be stopped approximately 4 weeks before the surgery date.
At that point, the potential recipient will be reimaged (CT scan). Test results, and inclusion and exclusion criteria will be reviewed to ensure the participant remains eligible to proceed to transplant. If these scans reveal any suspicion of tumor infiltration to surrounding tissues, an exploratory laparotomy or endoscopic ultrasound procedure will be scheduled to allow for visual examination and sampling of those tissues. Tissue samples, such as perihilar fat and/or lymph nodes, will be sent to the pathology department for urgent review. If extrahepatic disease is identified, the participant will be excluded from the study and the transplant will not be performed. Any excluded participants will continue to be followed for the study as "drop outs".
Otherwise, the donor and recipient surgeries will be performed in the standard fashion and with the preferred technique of the surgeon. The patient and donor will receive standard of care post-operative care.
Participants (recipients) will be monitored closely for evidence of tumor recurrence with imaging and blood tests. Results of these tests will be collected until completion of the study follow-up period (5-years after LT). In addition to tumor surveillance, liver transplant status will be assessed at each study timepoint (including graft loss, rejection, liver function tests, and details of immunosuppression). The study will also collect details of any biopsies performed, re-hospitalizations and surgical complications
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, aged 18 years or older, at time of consent
- Eastern Cooperative Oncology Group (ECOG) score : 0 or 1 at all times from study entry to LT
- Able and willing to provide written informed consent.
- Women of child-bearing potential must agree to use adequate birth control
- Histologically-confirmed diagnosis of iCCa
- Disease is deemed unresectable based on tumor location or underlying liver dysfunction
- No vascular invasion, extra-hepatic disease, or lymph node involvement detected on imaging
- Patients must have ≥ 6 months of disease stability or tumor regression on gemcitabine-based therapy. For patients who have progressed to second-line therapy, disease must also be controlled for ≥ 6 months on that regimen
- At least 1 living donor has stepped forward, is blood group compatible and has completed a "Health History form" which, upon review by the Living Donor team, is deemed acceptable and demonstrates no obvious contraindications to donation.
Exclusion Criteria:
- Previous or concurrent cancer (some exceptions permitted)
- Patients who have extrahepatic metastases, lymph node involvement, invasion or encasement of major hepatic vascular structures, perforation of the visceral peritoneum, invasion of extrahepatic structures, invasion of perihilar fat, periductular invasion, concurrent hepatoma or mixed hepatocellular cholangiocarcinoma
- Patients having received prior locoregional therapies or radiation to the tumor
- Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
- Known history of human immunodeficiency virus (HIV) infection.
- Prior history of solid organ or bone marrow transplantation
- 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 condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients (unless willing to abstain from breast-feeding)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: liver transplantation
Surgical Intervention - Liver transplantation
|
Surgical removal of liver containing tumor(s) and transplantation of new healthy liver graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
patient survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease-free survival
Time Frame: 5 years
|
5 years
|
patient survival
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gonzalo Sapisochin, MD, UHN
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-5581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cholangiocarcinoma, Intrahepatic
-
M.D. Anderson Cancer CenterActive, not recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Metastatic Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic CholangiocarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic Cholangiocarcinoma | Oligometastatic Intrahepatic CholangiocarcinomaUnited States
-
Emory UniversityNational Cancer Institute (NCI)WithdrawnStage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Resectable Intrahepatic Cholangiocarcinoma | Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8 | Stage I Intrahepatic Cholangiocarcinoma AJCC v8United States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH); CelgeneActive, not recruitingResectable Cholangiocarcinoma | Stage IB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8United States
-
Massachusetts General HospitalTerminatedResectable Intrahepatic Cholangiocarcinoma | Unresectable Intrahepatic CholangiocarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityActive, not recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Liver and Intrahepatic Bile Duct Carcinoma | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic CholangiocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Gallbladder Carcinoma | Metastatic Cholangiocarcinoma | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable CholangiocarcinomaUnited States
-
NRG OncologyNational Cancer Institute (NCI)TerminatedStage III Intrahepatic Cholangiocarcinoma | Stage IVA Intrahepatic CholangiocarcinomaUnited States, Canada
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnBile Duct Adenocarcinoma | Stage III Intrahepatic Cholangiocarcinoma | Stage IVA Intrahepatic Cholangiocarcinoma | Stage IVB Intrahepatic CholangiocarcinomaUnited States
-
Rutgers, The State University of New JerseyRecruitingIntrahepatic Cholangiocarcinoma | Cholangiocarcinoma, IntrahepaticUnited States
Clinical Trials on Liver Transplantation
-
University of ZurichUnknownDeath | ComplicationSwitzerland
-
Austral University, ArgentinaCompleted
-
Rutgers, The State University of New JerseyRecruitingIntrahepatic Cholangiocarcinoma | Cholangiocarcinoma, IntrahepaticUnited States
-
Oslo University HospitalRecruiting
-
University Health Network, TorontoCompleted
-
University of FloridaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminatedLiver Cancer | Hepatobiliary Tract Adenomas and CarcinomasUnited States
-
Republican Specialized Scientific and Practical...RecruitingLiver Cirrhosis | Liver Transplant; ComplicationsUzbekistan
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityNot yet recruitingLiver Metastases | Liver Transplant; Complications | Liver Cancer | Transplant | Transplant; Failure, Liver | Transplant; Complication, Rejection | Transplant Dysfunction
-
Hospital Vall d'HebronRecruitingColorectal Cancer | Liver Metastases | Genetic ChangeSpain
-
University of LiegeUniversitaire Ziekenhuizen KU Leuven; University Hospital, Ghent; University... and other collaboratorsRecruitingHepatocellular CarcinomaBelgium