Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Selective Internal Radiotherapy (SIRT) | Device | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine combined with SIRT
- description
- Patients in the experimental arm will be treated with capecitabine combined with Selective Internal Radiotherapy (SIRT) before surgery.
- interventionNames
- Drug: Capecitabine
- Device: Selective Internal Radiotherapy (SIRT)
- Procedure: Surgery
- type
- OTHER
- label
- Surgery only
- description
- Patients in the control group will receive surgery only.
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- Frequency of subjects with adequate surgical margins
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available