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New combo may extend life in tough pancreatic cancer

NCT ID NCT03943667

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 211 people with advanced pancreatic cancer whose first treatment (FOLFIRINOX) stopped working or caused too many side effects. Researchers compared a two-drug combination (gemcitabine and paclitaxel) against gemcitabine alone to see if the combo helped people live longer. The goal was to find a better second-line option for this hard-to-treat cancer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

211 people

The number who actually took part.

Started

May 2019

Finished

Apr 2022

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: * Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof * Age ≥18 years * At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area * Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days) * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 * Life expectancy ≥12 weeks * Negative serology (HIV, hepatitis B and C) * Adequate organs function * Proven Post-menopausal status or negative urinary or serum pregnancy test * Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment * Patients affiliated to the social security system * Patient must have signed a written informed consent form Exclusion Criteria: * Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri * Known cerebral metastasis * Uncontrolled severe infections * Patients with Kaposi's sarcoma * Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 * Previous treatment with taxane and/or gemcitabine (for pancreas cancer only) * Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient * Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment * Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial * Participation in another clinical trial within 14 days prior to randomization * Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced

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Conditions

The condition(s) this trial relates to.

pancreatic adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic adenocarcinoma

Contacts and locations

Locations

  • CH Simone Veil

    Beauvais, France

  • CH de Bayeux

    Bayeux, France

  • CH du Cotentin

    Cherbourg, France

  • CHU Jean Minjoz

    Besançon, France

  • CHU La Timone

    Marseille, France

  • CHU Rouen

    Rouen, France

  • CHU de Saint-Etienne

    Saint-Etienne, France

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Léon Bérard

    Lyon, France

  • Hospices civils de Lyon

    Lyon, France

  • Hôpital Broussais

    St-Malo, France

  • Hôpital Duchenne

    Boulogne-sur-Mer, France

  • Hôpital Européen de Marseille

    Marseille, France

  • Hôpital Nord Franche Comté

    Montbéliard, France

  • Hôpital Pitié-Salpétrière

    Paris, France

  • Hôpital Saint-Joseph

    Marseille, France

  • Hôpital Saint-Louis

    Paris, 75011, France

  • Hôpital Trousseau

    Tours, France

  • Institut Curie

    Saint-Cloud, France

  • Institut Godinot

    Reims, France

  • Institut Gustave Roussy

    Villejuif, France

  • Institut Mutualiste Montsouris

    Paris, 75014, France

  • Institut Paoli Calmettes

    Marseille, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.