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New treatment option for Resectable Intrahepatic Cholangiocarcinoma
Official title Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer
ClinicalTrials.gov ID: NCT05265208
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, being studied as a potential treatment for resectable intrahepatic cholangiocarcinoma.
Also referred to as L01BC06.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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,
You likely can't join if
- Pulmonary shunt with dose \>30Gy,
- Digestive shunting, non-correctible by treatment radiology,
- Absence of fixation of MAA in the tumour.
See the full eligibility criteria
- 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. Non-
- 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 treatment 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.
- Pulmonary shunt with dose \>30Gy,
- Digestive shunting, non-correctible by treatment radiology,
- Absence of fixation of MAA in the tumour.
The study team makes the final eligibility decision.
Where it's taking place
- Rennes, Brittany Region, France
- Pessac, New Aquitaine, France
- Montpellier, France
- Poitiers, France
- Villejuif, France
- Clichy, Île-de-France Region, France
- Créteil, Île-de-France Region, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rennes, Brittany Region, France; Pessac, New Aquitaine, France; Montpellier, France; Poitiers, France; Villejuif, France; Clichy, Île-de-France Region, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.