Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer

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

Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer (NCT05265208) is a Phase 2 interventional studying Resectable Intrahepatic Cholangiocarcinoma, sponsored by Center Eugene Marquis. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Resectable Intrahepatic Cholangiocarcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 62 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Resectable Intrahepatic Cholangiocarcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age \> 18 years-old, 2. ECOG Performance Status \<2, 3. Histologically-proven ICC, 4. No previous treatment for ICC, 5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board, 6. Significant risk of close margins, defined as: 1. Resection margin predicted by the surgeon \<1 cm 2. Tumour \>5 cm 3. Multifocal lesion deemed resectable, validated by a Surgical Review Board 7. Registration with a social security scheme, 8. Patient information and signature of willing to sign a consent form or legal representative. Non-Who May Qualify: 1. Severe fibrosis (F3) ou cirrhosis (F4), 2. Inadequate haematological, hepatic, renal and coagulation functions: 1. Haemoglobin ≤ 8,5 g/dl 2. Neutrophils \< 1,5 Giga/L 3. Platelets \< 60 Giga/L 4. Bilirubin \> 34 µmol/L 5. ASAT/ALAT \> 5 x ULN 6. Creatinine clearance \< 30 ml/min (MDRD) 7. TP et INR \> 2,3 ULN 8. TCA \> 1,5 x ULN 3. Uracil blood level \>16 ng/mL, 4. Respiratory insufficiency, 5. Comorbidity precluding surgical resection, such as severe heart disease, 6. Presence of microvacuolar steatosis \> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned, 7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis), 8. Previous chemotherapy (including for another cancer), 9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer), 10. Other invasive malignancies, 11. Patient participate to an interventional study that tests another medical intervention before surgery, 12. 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, 13. Minors, individual deprived of liberty, or under any kind of guardianship, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age \> 18 years-old, 2. ECOG Performance Status \<2, 3. Histologically-proven ICC, 4. No previous treatment for ICC, 5. Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board, 6. Significant risk of close margins, defined as: 1. Resection margin predicted by the surgeon \<1 cm 2. Tumour \>5 cm 3. Multifocal lesion deemed resectable, validated by a Surgical Review Board 7. Registration with a social security scheme, 8. Patient information and signature of informed consent or legal representative. Non-inclusion Criteria: 1. Severe fibrosis (F3) ou cirrhosis (F4), 2. Inadequate haematological, hepatic, renal and coagulation functions: 1. Haemoglobin ≤ 8,5 g/dl 2. Neutrophils \< 1,5 Giga/L 3. Platelets \< 60 Giga/L 4. Bilirubin \> 34 µmol/L 5. ASAT/ALAT \> 5 x ULN 6. Creatinine clearance \< 30 ml/min (MDRD) 7. TP et INR \> 2,3 ULN 8. TCA \> 1,5 x ULN 3. Uracil blood level \>16 ng/mL, 4. Respiratory insufficiency, 5. Comorbidity precluding surgical resection, such as severe heart disease, 6. Presence of microvacuolar steatosis \> 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned, 7. Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis), 8. Previous chemotherapy (including for another cancer), 9. Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer), 10. Other invasive malignancies, 11. Patient participate to an interventional study that tests another medical intervention before surgery, 12. 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, 13. Minors, individual deprived of liberty, or under any kind of guardianship, 14. Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons. Exclusion Criteria: 1. Pulmonary shunt with dose \>30Gy, 2. Digestive shunting, non-correctible by interventional radiology, 3. Absence of fixation of MAA in the tumour.

Treatments Being Tested

DRUG

Capecitabine

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.

DEVICE

Selective Internal Radiotherapy (SIRT)

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.

PROCEDURE

Surgery

Surgery will be performed according to local practice.

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

Groupe SUD-Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux

Pessac, New Aquitaine, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Gustave Roussy

Villejuif, France

Hôpital Beaujon

Clichy, Île-de-France Region, France

Hôpital Henri - Mondor

Créteil, Île-de-France Region, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05265208), the sponsor (Center Eugene Marquis), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05265208 clinical trial studying?

Who can participate in NCT05265208?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05265208?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05265208. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05265208. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.