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Liver-targeted chemo shows promise for tough bile duct cancer

NCT ID NCT03364530

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Amiens, France

  • Angers University Hospital

    RECRUITING

    Angers, France

  • Bordeaux University Hospital

    RECRUITING

    Bordeaux, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, France

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Uhmontpellier

    RECRUITING

    Montpellier, 34295, France

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