New combo therapy targets rare abdominal cancer
NCT ID NCT03875144
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a special chemotherapy spray (PIPAC) directly into the abdomen to standard IV chemo can help people with a rare cancer of the belly lining (peritoneal mesothelioma) live longer. About 66 adults who have not had prior treatment will be randomly assigned to receive either standard chemo alone or standard chemo plus PIPAC. The trial is currently suspended.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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. PS (or WHO) \<2 3. Histologically-confirmed diagnosis of peritoneal malignant mesothelioma 4. No previous line of treatment (both medical and surgical oncologic treatments) for this disease 5. Peritoneal Carcinomatosis Index (PCI)\>27 or at least 4 on the small bowel with serosal involvement contraindicating the cytoreductive surgery because of the impossibility to preserve a length \>=1.5 m of uninvolved small bowel 6. Written and dated informed consent 7. Affiliated to the French national social security system Exclusion Criteria: 1. WHO performance status ≥ 2 2. Any contraindication to chemotherapy and/or radiotherapy 3. Any contraindication to repeated laparoscopy 4. Symptomatic cardiac or coronary insufficiency 5. Severe renal insufficiency 6. Progressive active infection or any other severe medical condition 7. Intestinal occlusion non responsive to medical treatment 8. Other cancer treated within the last 2 years except in situ cervical carcinoma or basocellular/spinocellular carcinoma 9. Pregnant or breast-feeding woman 10. Previously operated patients where laparoscopy is not feasible 11. Persons deprived of liberty or under guardianship or incapable of giving consent 12. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Institut réginal du Cancer de Montpellier
Montpellier, 34298, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can heated chemotherapy during surgery extend life for peritoneal cancer patients?
- Lab-Grown tumor models may predict who benefits from heated chemotherapy
- Can Lab-Grown tumor models predict the best therapy for each patient?
- Abdominal chemotherapy after surgery may improve mesothelioma outcomes
- Triple chemo cocktail aims to clear deadly bowel blockages in advanced stomach cancer
- Chemotherapy sprayed directly into the abdomen: a new attack on stubborn cancers