New Drug-Coated membrane targets sarcoma after surgery
NCT ID NCT04619056
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
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Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
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Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
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Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
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