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Can a simple protein improve recovery from heated chemo surgery?

NCT ID NCT06351475

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a protein called albumin to standard IV fluids during a major cancer surgery (cytoreduction with heated chemotherapy) can reduce complications. 140 adults undergoing this surgery will be randomly assigned to receive either standard fluids or standard fluids plus albumin. The main goal is to see if the albumin group has fewer complications 28 days after surgery.

What this could mean

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

Active substance
20% human albumin
What this could lead to
If it works, this could lead to a safer fluid management strategy during complex cancer surgery, reducing postoperative complications.
What could go wrong
This is a relatively small, early-stage trial (140 patients) testing a well-known drug in a new setting. The benefit may be small or not seen at all, and albumin is expensive with potential allergic reactions.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2027

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 to 80 years

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: * Male and female patients aged 18 years old and older * Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin) * Patient volunteer for the study and provided written informed consent * Patient affiliated to the French Health Insurance Exclusion Criteria: * Adults \>75 years old * Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG \> 2 or Karnofsky index \< 75) * Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition) * Severe preoperative hypoalbuminemia (albuminemia \< 20 g/L) * History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction \< 40%) * Patients at high risk of perioperative and postoperative pulmonary complications (atelectasis, significant pleural effusions) * Significant ascites with preoperative respiratory repercussions * Uncontrolled diabetes (HbA1c \> 8.5%) * Allergy to exogenous human albumin and its excipients. * Contraindication to the administration of Ringer's lactate (history of allergy) * Hyperkalemia \> 6.0 mmol/L * Hypercalcemia (total calcium \> 2.60 mmol/L) * Chronic use of digitalis and hyperkalemic diuretics * Pregnancy, breastfeeding * Known preoperative renal failure (GFR \< 30 mL/min/1.73m2 or extrarenal purification) * Recent brain trauma \< 6 months (traumatic, ischemic, or hemorrhagic) * Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable * Patient deprived of liberty * Patient under guardianship or curatorship

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Conditions

The condition(s) this trial relates to.

peritoneal carcinomatosis peritoneal neoplasm Postoperative Complications

As listed by the trial registrant

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

Fluid therapy Hyperthermic intraperitoneal chemotherapy Intraoperative care Peritoneal neoplasms Postoperative complications

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

  • Gustave Roussy Institute

    RECRUITING

    Villejuif, France

  • Hôpital Hautepierre / UIC ARMO

    RECRUITING

    Strasbourg, France

  • Institut régional du Cancer de Montpellier

    RECRUITING

    Montpellier, France

  • La Pitié Salpetriere hospital

    RECRUITING

    Paris, 75013, France

  • Lariboisière hospital

    RECRUITING

    Paris, France

  • Robert Debré hospital

    RECRUITING

    Reims, France

  • Saint Louis hospital

    RECRUITING

    Paris, France

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