New hope for mesothelioma patients who Can't have surgery?
NCT ID NCT05449366
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a chemotherapy drug called paclitaxel, given directly into the abdomen, for people with a rare cancer called malignant peritoneal mesothelioma. The 7 participants could not have standard surgery. The main goal was to find the safest dose and see if the treatment is feasible. Researchers also checked for side effects and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paclitaxel (chemotherapy drug given directly into the abdomen)
- What this could lead to
- If successful, this could provide a new treatment option for patients with peritoneal mesothelioma who cannot have surgery, potentially controlling the disease and improving survival.
- What could go wrong
- This is a very small, early-phase study (only 7 participants) focused on finding the right dose and checking safety. It is not designed to prove the treatment works, and side effects from chemotherapy are expected.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
7 people
The number who actually took part.
- Started
-
Feb 2022
- Finished
-
Aug 2025
- 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 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: * Histological confirmed diagnosis of malignant peritoneal mesothelioma * Patients that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) * Age ≥ 18 years old * Written informed consent according to the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and national/local regulations * Patients must be ambulatory, i.e. World Health Organization-Eastern Cooperative Oncology Group (WHO-ECOG) performance status 0 or 1 * Ability to return to the Erasmus Medical Center for adequate follow-up as required by this protocol * Patients must have normal organ function and adequate bone marrow reserve as assessed by the following laboratory requirements; absolute neutrophil count \>1.5 \* 10\^9/l, platelet count \>100\*10\^9/l and Hemoglobin \>6.0mmol /l. Patients must have a Bilirubin \<1½ x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 x ULN Exclusion Criteria: * Extra-abdominal disease/metastatic disease established by preoperative CT-scan of thorax-abdomen and/or PET-scan. Imaging not older than two months at time of surgery * Medical or psychological impediment to probable compliance with the protocol * Serious concomitant disease or active infections * History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis * Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for participation in this study * Pregnant or lactating women; for all women of child-bearing potential a negative urine pregnancy test will be required as well as the willingness to use adequate contraception during the study until 4 weeks after finishing treatment * Absence of assurance of compliance with the protocol * An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up
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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
-
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA, Netherlands
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