Intrahepatic CholangiocarcinomaRIS-THNCT06910722
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
A study testing Liver transplant in people with Intrahepatic Cholangiocarcinoma and Locally Advanced Intrahepatic Cholangiocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Locally Advanced Intrahepatic Cholangiocarcinoma
- What is being tested?
- Liver transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2025to 1 Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 65
- With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
- Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))
- Without extrahepatic or lymph node involvement
- Technically unresectable R0 according to an expert panel
- Tumor target > 2 cm
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- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Severe untreatable conditions
- Recent history (less than 5 years) of cancer
- severe comorbidities
- Psychiatric or psychological disorders
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Beaujon
Clichy-sous-Bois
Mohamed BOUATTOUR, mohamed.bouattour@aphp.fr
About this study
Official title: Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
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.
Read the detailed description
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.
- Being tested
- Liver transplant
- Keywords
- liver transplantation, locally advanced intrahepatic cholangiocarcinoma, selective internal radiation therapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantProcedure or surgery
follow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years post-transplant
Secondary outcomes (11)
Strategy feasibility 1/2
Number of patients benefiting from the complete strategy implemented
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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;.
Measured: 5 years after strategy implementation
oncological prognosis1/2
Number of patients not transplanted alive at 3 years (with or without recurrence)
Measured: after 8 courses of chemotherapy
oncological prognosis 2/2
Time to onset, type and location of recurrence in transplanted and non-transplanted patients
Measured: 5 years after strategy implementation
Histological response
Rate of tumor necrosis on total hepatectomy specimens in transplant patients
Measured: 1 year after strategy implementation
Tolerance of neoadjuvant treatment
Number and type of adverse events induced by neoadjuvant therapy
Measured: 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
Measured: 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.
Measured: from induction therapy until 3 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start28 Aug 2025
- Primary completion28 Aug 2028 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Bouattour, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910722
- Sponsor's protocol ID
- APHP220677
- Acronym
- RIS-TH
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
- ClinicalTrials.gov ID
- NCT06910722
- Acronym / sponsor ID
- RIS-TH / APHP220677
- Keywords
- liver transplantation, locally advanced intrahepatic cholangiocarcinoma, selective internal radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 28 Aug 2028 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplant patients | Experimental | Procedure: Liver transplantLiver transplantation performed after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient aged 18 to 65
- With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
- Tumor target > 2 cm
- WHO 0-1
- free and informed consent signed
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantfollow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy | Procedure or surgery | liver transplant patients |
Primary outcome
Strategy efficacy : 3 years overall survival
Time frame: 3 years post-transplant
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.
11 secondary outcomes
Strategy feasibility 1/2
Time frame: Liver transplantation
Strategy feasibility 2/2 contraindication to transplantation
Time frame: Liver transplantation
Associated factors with the 3-years overall survival
Time frame: 3 years after strategy implementation
therapeutic efficacy at 3 years
Time frame: 3 years after strategy implementation
therapeutic efficacy at 5 years
Time frame: 5 years after strategy implementation
oncological prognosis1/2
Time frame: after 8 courses of chemotherapy
oncological prognosis 2/2
Time frame: 5 years after strategy implementation
Histological response
Time frame: 1 year after strategy implementation
Tolerance of neoadjuvant treatment
Time frame: after 8 courses of chemotherapy
quality of life monitoring
Time frame: from induction therapy until 5 years post-transplant
Tolerance of global strategy
Time frame: from induction therapy until 3 months post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Bouattour principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplant in people with Intrahepatic Cholangiocarcinoma and Locally Advanced Intrahepatic Cholangiocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed BOUATTOUR (1.40.87.56.14 ext. +33, mohamed.bouattour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strategy efficacy : 3 years overall survival (time frame: 3 years post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.