Resectable Intrahepatic CholangiocarcinomaPhase 2SIROCHONCT05265208
Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
A Phase 2 study testing Capecitabine, Selective Internal Radiotherapy (SIRT) and Surgery in people with Resectable Intrahepatic Cholangiocarcinoma, run by Center Eugene Marquis at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Intrahepatic Cholangiocarcinoma
- What is being tested?
- Capecitabine, Selective Internal Radiotherapy (SIRT) and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 7 sitesFrance
- Study dates
- 4 Feb 2022to 4 Feb 2030
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 34Show fewer
- 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.
- Non-inclusion Criteria:
- Severe fibrosis (F3) ou cirrhosis (F4),
- Inadequate haematological, hepatic, renal and coagulation functions:
- Haemoglobin ≤ 8,5 g/dl
- Neutrophils < 1,5 Giga/L
- Platelets < 60 Giga/L
- Bilirubin > 34 µmol/L
- ASAT/ALAT > 5 x ULN
- Creatinine clearance < 30 ml/min (MDRD)
- TP et INR > 2,3 ULN
- TCA > 1,5 x ULN
- Uracil blood level >16 ng/mL,
- Respiratory insufficiency,
- Comorbidity precluding surgical resection, such as severe heart disease,
- Presence of microvacuolar steatosis > 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned,
- Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis),
- Previous chemotherapy (including for another cancer),
- Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer),
- Other invasive malignancies,
- Patient participate to an interventional study that tests another medical intervention before surgery,
- Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant,
- Minors, individual deprived of liberty, or under any kind of guardianship,
- Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.
Who cannot join
- Pulmonary shunt with dose >30Gy,
- Digestive shunting, non-correctible by interventional radiology,
- Absence of fixation of MAA in the tumour.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Hôpital Beaujon
Clichy, Île-de-France Region, 92118
Mohamed Bouattour, MD
Clémence Hollande, MD
- Recruiting
Hôpital Henri - Mondor
Créteil, Île-de-France Region, 94000
Hélène Régnault, MD
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Astrid Herrero, MD
- Recruiting
Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux
Pessac, New Aquitaine, 33604
Jean - Frédéric Bland, MD PHD
Bérénice Teulières, MD
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
David Tougeron, MD PHD
- Recruiting
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042
Julien Edeline, MD PHD
Samuel Lesourd, MD
- Recruiting
Gustave Roussy
Villejuif, 94805
Lambros Tselikas, MD
Michel Ducreux, MD
About this study
Official title: 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
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.
Read the detailed description
The study plans to randomized eligible and consent patients in two balanced parallel groups, the one defined as the experimental arm while the second consisting in the actual standard of care is defined as the control standard arm.
The experimental arm consists in 12 weeks of capecitabine combined with SIRT as neoadjuvant treatment followed by surgery. After SIRT, patients will be assessed at 10 weeks with thoracic-abdominal and pelvic CT scan and liver MRI. If the tumour is still deemed resectable, surgery will be performed at 16 weeks.
In case of discovery of contra-indication to SIRT after inclusion (such as described in the SIRT exclusion criteria section) patients will stop chemotherapy and proceed to surgery within one month. The concerned patients are still included in the study and continue the post-surgery follow-up as expected by the protocol.
In the control arm, patients will proceed to upfront surgery.
The follow - up period begins just after the surgery in both arm, and the patients are evaluated every 3 months for 2 years, then every 6 months for 3 additional years, clinically by an oncologist and radiologically with thoracic-abdominal and pelvic CT scan.
Whether progression occurred, patients will no longer be followed according to the protocol; only vital status continues to be collected until the end of the study (i.e. the last visit of the last patient).
- Being tested
- Capecitabine, Selective Internal Radiotherapy (SIRT), Surgery
- Keywords
- Selective Internal Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called L01BC06
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.
Selective Internal Radiotherapy (SIRT)Device
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.
SurgeryProcedure or surgery
Surgery will be performed according to local practice.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine combined with SIRT | Experimental | Patients in the experimental arm will be treated with capecitabine combined with Selective Internal Radiotherapy (SIRT) before surgery. Receives: Drug: Capecitabine; Device: Selective Internal Radiotherapy (SIRT); Procedure: Surgery |
| Surgery only | Other | Patients in the control group will receive surgery only. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start4 Feb 2022
- Primary completion4 Sep 2027 (estimated)
- Study completion4 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Edeline, MD, Principal investigator, Centre de Lutte contre le Cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265208
- Sponsor's protocol ID
- 2017-02-32-005
- Other IDs
- 2021-001575-16
- Acronym
- SIROCHO
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No