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NCT06281860: PITHAC

Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration

Status unknown Phase 1 Last updated 28 February 2024
What this trial tests

Phase 1 trial testing Cisplatine Teva® in Mesothelioma, Malignant in 39 participants. Status unknown.

Timeline
24 November 2023
Primary endpoint
1 December 2025
1 February 2026

Quick facts

Lead sponsorDr Jean Yannis PERENTES
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment39
Start date24 November 2023
Primary completion1 December 2025
Estimated completion1 February 2026
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Dr Jean Yannis PERENTES — full company profile →

Who can join

18 and older, any sex, with Mesothelioma, Malignant or Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting Neoantigens in Cancer: Possibilities and Opportunities in Breast Cancer.
    Chaudhry Z, Boyadzhyan A, Sasaninia K, Rai V. · · 2024 · cited 3× · PMID 38920970 · DOI 10.3390/antib13020046
  2. Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis.
    Chriqui LE, Abdelnour-Berchtold E, Zanfrini E, Devesa-Perez S, et al · · 2024 · cited 1× · PMID 39708537 · DOI 10.1016/j.ctarc.2024.100858
  3. The Evolving Role of Chemotherapy in the Management of Pleural Malignancies: Current Evidence and Future Directions.
    Semenova Y, Burkitbayev Z, Kalibekov N, Digay A, et al · · 2025 · PMID 40647443 · DOI 10.3390/cancers17132143

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing