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Diabetes drug januvia tested to boost immune attack on liver cancer

NCT ID NCT02650427

Disease control Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested the safety of giving sitagliptin (Januvia) for three weeks to 14 liver cancer patients before they had surgery to remove their tumors. The idea is that sitagliptin might help immune cells get into the tumor and fight it better. The main goal was to check for side effects, not to see if the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sitagliptin (Januvia)
What this could lead to
If it works, this could point toward a way to boost the immune system's ability to fight liver cancer after surgery.
What could go wrong
This is a very early, small Phase 1 safety study with only 14 people. It is not designed to prove the drug works against cancer, and side effects are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Feb 2016

Finished

Sep 2018

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Patients with 18 years old the day of inclusion. * For women, a negative blood pregnancy test before inclusion is necessary. Note: this test will be done only to women of childbearing age and non menopausal. * HCC based on medical imaging with indication of liver resection and without contra-indication of preoperative liver biopsy. * Minor resection not exceeding 2 liver segments * No cirrhosis or cirrhosis with a Child-Pugh Score Class A. Note: this score is used worldwide to assess liver function in cirrhosis. * Informed consent must be obtained for all subjects prior to study entry. * Patients affiliated to health policy insurance. Exclusion Criteria: * Presence of HIV Infection. * Presence of renal impairment (CrCl \<60 ml / min). * Liver function compromised (Child Pugh B, MELD score \> 9) * Indirect sign of portal hypertension (Oesophagal Varices, splenomegaly, platelet count less than 100.000) * A need for major hepatic resection (more than 2 segments) * Taking digoxin (digitalis) within 6 months of starting treatment. * History of severe hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin. * Patients with diabetes. * Pregnant or absence of an effective contraception for women. * A person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure. * Living conditions suggesting an inability to track all scheduled visits by the protocol. * Life expectancy less than 3 months.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

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

Hepato carcinoma

Contacts and locations

Locations

  • Pitié-Salpêtrière Hospital

    Paris, 75013, France