Liver-targeted chemo shows promise for tough bile duct cancer
NCT ID NCT03364530
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests giving chemotherapy drugs (gemcitabine and oxaliplatin) directly into the liver's main artery for people with advanced bile duct cancer that hasn't spread elsewhere. The goal is to shrink tumors while reducing side effects. About 40 adults who have already tried one standard treatment will receive this therapy. The main measure of success is whether tumors shrink at least 30% after 4 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine and oxaliplatin chemotherapy
- What this could lead to
- If successful, this could offer a new second-line treatment option to shrink liver tumors in patients with advanced bile duct cancer that hasn't spread.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The treatment involves invasive catheter placement and carries risks like infection or liver damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2018
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically-proven intrahepatic cholangiocarcinoma previously treated by first-line systemic therapy * Absence of extra-hepatic metastasis or peritoneal carcinomatosis (as demonstrated by CT-scan) * General health status : World Health Organization Performance Status = 0, 1 * Estimated life expectancy \> 3 months * Disease that is not suitable for resection with a curative intent, as validated by a multidisciplinary committee with at least one senior hepatic surgeon * At least one measurable lesion according to RECIST 1.1 criteria * Platelets ≥100,000/mm3, polynuclear neutrophils ≥ 2000/mm3 , hemoglobin 9g/dL (even transfused patients can be included) * Creatininemia \< 1.5 mol/L * Creatinine clearance \> 30 mL/min * Bilirubinemia ≤2 N (after biliary drainage if necessary) * Aspartate and Alanine Transaminase ≤ 5 mol/L * Reference hepatic MRI (according to the foreseen protocol) done during the 30 days preceding the 1st cycle of treatment * Written informed consent * National health insurance cover Exclusion Criteria: * Patients with cholangiocarcinoma of the gallbladder or common bile duct or those with hepatocholangiocarcinoma or a Klatskin tumor * Patients who are eligible for surgical resection or liver transplantation * Extra-hepatic metastases (Pulmonary micronodules \<7mm without uptake on positron emission tomography are not a contra-indication) * Presence of clinical ascites * History of intra-arterial therapy or more than one line of systemic treatment * Contra-indication or grade 3-4 allergy to any of the treatment drugs Gemcitabine, Oxaliplatin (notably myelosuppression developped before the beginning of the first cycle of therapy, peripheral sensory neuropathy before the first cycle of therapy, severe renal failure) * Grade 2 peripheral neuropathy * Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug * Concomitant systemic treatment with immunotherapy, chemotherapy or hormone therapy * Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment * Pregnancy (beta-human chorionic gonadotropin positive), breast-feeding or the absence of effective contraception for women of child-bearing age * Another cancer in the 5 years preceding or at the time of inclusion in the trial (except for in situ cervical cancer or basal cell carcinoma of the skin) * Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients) * Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 12 hours * Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix. * Contra-indication for use of an intra-arterial approach (severe arteriopathy) * Legal incapacity (persons in custody or under guardianship) * Deprived of liberty Subject (by judicial or administrative decision) * Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons * Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cholangiocarcinoma non-resectable are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
7 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Amiens University Hospital
RECRUITINGAmiens, France
-
Angers University Hospital
RECRUITINGAngers, France
-
Bordeaux University Hospital
RECRUITINGBordeaux, France
-
Centre Georges François Leclerc
RECRUITINGDijon, France
-
Hôpital Européen Georges Pompidou
RECRUITINGParis, France
-
Institut Gustave Roussy
RECRUITINGVillejuif, France
-
Uhmontpellier
RECRUITINGMontpellier, 34295, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can shrinking pancreatic tumors before surgery improve outcomes?
- Triple attack on bile duct cancer: chemo, targeted drug, and immunotherapy aim to make the inoperable operable
- New drug CT-95 targets tough cancers in early trial
- Triple therapy takes on bile duct cancer: hope for unresectable cases
- New trial aims to save rectums in rectal cancer patients
- Blood tests and patient surveys could improve bile duct cancer monitoring