Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.
It is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases. Participants will be recruited from care facilities in France.
The hypothesis of the study is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve the overall 3-year survival of patients with locally advanced intrahepatic cholangiocarcinoma (unresectable but not metastatic).
All patients over 18 and under 65 years of age with histologically evidence, pauci-nodular (N≤5), locally advanced Intrahepatic cholangiocarcinoma (IHC) without extrahepatic involvement, considered technically unresectable by a panel of experts, eligible for treatment with SIRT, gemcitabine + cisplatin chemotherapy and Liver Transplant (LT).
Following treatment with SIRT + chemotherapy, tumor response or absence of tumor progression will be verified by a morphological workup combining CT-imaging, hepatic MRI and PET-CT.
After exploratory surgery to rule out any contraindications for LT, the patient will be list , with a minimum waiting of 3-month Follow-up will include assesment of Liver graft function, efficiency and tolerance of immunosuppressive therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liver transplant patients | Experimental | Liver transplantation performed after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver transplant | Procedure | follow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Strategy efficacy : 3 years overall survival | To assess the 3-year overall survival of patients undergoing liver transplantation for stable or downstaged locally advanced intrahepatic cholangiocarcinoma after induction treatment with selective internal radiotherapy and chemotherapy. | 3 years post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Strategy feasibility 1/2 | Number of patients benefiting from the complete strategy implemented | Liver transplantation |
| Strategy feasibility 2/2 contraindication to transplantation | Number of patients with radiological tumor progression according to RECIST 1.1 criteria after neoadjuvant treatment contraindicating transplantation |
Not provided
Inclusion Criteria:
Patient aged 18 to 65
With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
Tumor target > 2 cm
WHO 0-1
free and informed consent signed
highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH
Exclusion Criteria:
Extrahepatic, vesicular or perihilar cholangiocarcinoma
Tumor infiltration of more than 50% of the liver
Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
Previous treatment for CCI
Cirrhosis ≥ Child B7
Chronic alcoholism
Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)
Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml/min)
Contraindications to liver transplant
Pregnant or breast-feeding women
Patient under guardianship
Not affiliated to a Health care system
Participating in another interventional study or within the exclusion period of a previous study involving the human body
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed BOUATTOUR | Contact | 1.40.87.56.14 | +33 | mohamed.bouattour@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Bouattour | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaujon | Recruiting | Clichy-sous-Bois | France |
Not provided
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Liver transplantation |
| Associated factors with the 3-years overall survival | Socio-demographic and clinico-radio-biological characteristics at baseline and follow-up of living patients 3 years after strategy implementation. | 3 years after strategy implementation |
| therapeutic efficacy at 3 years | Number of transplant patients alive and free of recurrence at 3 years after strategy implementation, as well as their socio-demographic and clinico-radiobiological characteristics at baseline and follow-up. | 3 years after strategy implementation |
| therapeutic efficacy at 5 years | Number of transplanted patients alive 5 years after the strategy was implemented and number of transplanted patients alive and free of recurrence for the same period;. | 5 years after strategy implementation |
| oncological prognosis1/2 | Number of patients not transplanted alive at 3 years (with or without recurrence) | after 8 courses of chemotherapy |
| oncological prognosis 2/2 | Time to onset, type and location of recurrence in transplanted and non-transplanted patients | 5 years after strategy implementation |
| Histological response | Rate of tumor necrosis on total hepatectomy specimens in transplant patients | 1 year after strategy implementation |
| Tolerance of neoadjuvant treatment | Number and type of adverse events induced by neoadjuvant therapy | after 8 courses of chemotherapy |
| quality of life monitoring | Changes in scores on the SF-36 quality-of-life questionnaire administered after neoadjuvant treatment prior to TH and then annually between the first and fifth years of follow-up | from induction therapy until 5 years post-transplant |
| Tolerance of global strategy | Number of adverse events of grade greater than or equal to 3 (NCI CTCAE) during neoadjuvant treatment + Number of severe complications greater than or equal to 3 of the Clavien-Dindo classification within 90 days of TH. | from induction therapy until 3 months post-transplant |
| D009369 | Neoplasms |
| D013505 |
| Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |