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New Drug-Coated membrane targets sarcoma after surgery

NCT ID NCT04619056

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a special membrane loaded with the drug SN-38 in 21 people with recurrent or advanced retroperitoneal sarcoma. The membrane was placed in the surgical area after tumor removal to see if it is safe and tolerable. The goal is to find the right dose and check for side effects.

What this could mean

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

Active substance
CEB-01 membrane loaded with SN-38 (a chemotherapy drug)
What this could lead to
If successful, this could lead to a new treatment option that helps prevent sarcoma from coming back after surgery.
What could go wrong
This is a very early Phase 1 trial with only 21 people, so safety and dosing are still being figured out. It may not work or could have side effects.

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

21 people

The number who actually took part.

Started

Jun 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Age \>18 years. 2. Histologically confirmed diagnosis of locally advanced (T3 -T4, American Joint Committee on Cancer (AJCC)/primary tumor, regional lymph nodes, and distant metastases staging system (TMN) 8th Edition) and/or relapsed (any) retroperitoneal soft tissue sarcoma (liposarcoma, leiomyosarcoma, a solitary fibrous tumor (SFT), pleomorphic sarcoma, or a malignant nerve sheath tumor). Patients with local advanced (T3 -T4,AJCC/TMN 8th Edition) and/or relapse and metastatic disease who are candidates for local surgery without option of systemic treatment, are also eligible for the trial. 3. Pathology specimens available for centralized review. Submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central reviewing is required; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted. 4. Size of tumor (visible or previously inadequately resected) \>5 cm at instrumental staging (CT, MRI). 5. Normal liver, renal, hematological, and cardiac function as defined by biochemical and hematological parameters as follows: Hb \>11 g/dL, platelets \>100.000/mm3, White Blood Cells (WBC) \>3000/mm3, neutrophil count \>1500/mm3, albumin \>3.0 g/dl, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \<2.5 times the upper limit of normality (ULN), bilirubin \<2 times the ULN, creatinine \<1.5 mg/dl or creatinine clearance \> 60 ml/min. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status \<2. 7. No concomitant radiotherapy or chemotherapy planned. 8. Life expectancy greater than 6 months. 9. Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening. 10. Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 3 months after surgery. 11. Ability to understand and the willingness to sign a written informed consent document; subject has signed an Informed Consent Form (ICF) prior to any screening procedures and is able to comply with protocol requirements. Exclusion Criteria: 1. Pregnancy or lactation. Note: Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued. 2. Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent. 3. Serious psychiatric disease that precludes informed consent or limits compliance 4. Medical condition limiting survival to less than 6 months. 5. Uncontrolled bacterial, viral or fungal infection. 6. Active viral hepatitis or chronic liver disease. 7. Impossibility of ensuring adequate follow-up. 8. Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or an aneurysm clip, severe claustrophobia, a known reaction to the gadolinium contrast dye, or body weight that could interfere with the feasibility of a MRI. 9. Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumor biopsy nor central line insertion are considered a major surgery. 10. Unable or unwilling to stop the use of herbal supplements; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation. 11. Other relevant concomitant illnesses. 12. Patients previously treated with Irinotecan.

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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.

Contacts and locations

Locations

  • Fundación Jiménez Díaz

    Madrid, Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, Madrid, 28007, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

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