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A phase II study evaluating the efficacy of Selective Internal Radiation Therapy combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma
EU CTIS ID: 2024-516683-29-00
What this study is testing
To assess efficacy of the combination of neoadjuvant SIRT and capecitabine in neoadjuvant setting of patients with resectable cholangiocarcinoma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: Resection margin predicted by the surgeon <1cm or Tumour > 5cm or Multifocal lesion deemed resectable, validated by a Surgical Review Board
You likely can't join if
- 1. Severe fibrosis (F3) ou cirrhosis (F4)
- 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
See the full eligibility 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: Resection margin predicted by the surgeon <1cm or Tumour > 5cm or 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
- 1. Severe fibrosis (F3) ou cirrhosis (F4)
- 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
- 2. 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
- 3. Uracil blood level >16 ng/mL
- 4. Respiratory insufficiency
- 5. Significant heart disease or history of heart rhythm disorders, myocardial infarction or angina pectoris in the 6 months prior to inclusion
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.