Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
SIROCHO
A Multicenter Open-label Randomized Controlled Prospective Phase II Study Evaluating the Efficacy of Selective Internal Radiation Therapy (Yttrium-90 Glass Microspheres) Combined With Capecitabine in the Neoadjuvant Setting of Operable Intrahepatic CHOlangiocarcinoma
2 other identifiers
interventional
62
1 country
7
Brief Summary
Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (\<5mm) margins having a higher risk of recurrence. Selective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics. Given the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2022
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2022
CompletedStudy Start
First participant enrolled
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 4, 2030
August 6, 2025
August 1, 2025
5.6 years
January 25, 2022
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of subjects with adequate surgical margins
The primary endpoint will be the frequency of subjects with adequate surgical margins, defined as the number of resections AND margin ≥ 5mm.
through study completion, an average of 5 year
Study Arms (2)
Capecitabine combined with SIRT
EXPERIMENTALPatients in the experimental arm will be treated with capecitabine combined with Selective Internal Radiotherapy (SIRT) before surgery.
Surgery only
OTHERPatients in the control group will receive surgery only.
Interventions
Capecitabine will given at 1250mg/m², 2 times a day with an interval of about 12 hours between two intakes, 2 weeks on, 1 week off, for 4 pre-surgery cycles.
During the first week of cycle 2 of capecitabine, patients will receive SIRT using Yttrium-90 glass microspheres. Treatment with Yttrium-90 glass microspheres requires two steps, one or two weeks apart. Both stages are performed under local anesthesia after a short hospitalization : the treatment simulation and therapeutic angiography.
Surgery will be performed according to local practice.
Eligibility Criteria
You may qualify if:
- Age \> 18 years-old,
- ECOG Performance Status \<2,
- Histologically-proven ICC,
- No previous treatment for ICC,
- Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board,
- Significant risk of close margins, defined as:
- Resection margin predicted by the surgeon \<1 cm
- Tumour \>5 cm
- Multifocal lesion deemed resectable, validated by a Surgical Review Board
- Registration with a social security scheme,
- Patient information and signature of informed consent or legal representative.
- Severe fibrosis (F3) ou cirrhosis (F4),
- Inadequate haematological, hepatic, renal and coagulation functions:
- Haemoglobin ≤ 8,5 g/dl
- Neutrophils \< 1,5 Giga/L
- +18 more criteria
You may not qualify if:
- Pulmonary shunt with dose \>30Gy,
- Digestive shunting, non-correctible by interventional radiology,
- Absence of fixation of MAA in the tumour.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042, France
Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux
Pessac, Nouvelle-Aquitaine, 33604, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Gustave Roussy
Villejuif, 94805, France
Hôpital Beaujon
Clichy, Île-de-France Region, 92118, France
Hôpital Henri - Mondor
Créteil, Île-de-France Region, 94000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien Edeline, MD
Centre de Lutte contre le Cancer Eugène Marquis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2022
First Posted
March 3, 2022
Study Start
February 4, 2022
Primary Completion (Estimated)
September 4, 2027
Study Completion (Estimated)
February 4, 2030
Last Updated
August 6, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share