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NCT05410483

A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

Status unknown Phase 1 Last updated 8 June 2022
What this trial tests

Phase 1 trial testing Docetaxel in Hyperthermic Intraperitoneal Chemotherapy in 30 participants. Status unknown.

Timeline
1 March 2022
Primary endpoint
1 February 2023
1 February 2023

Quick facts

Lead sponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 March 2022
Primary completion1 February 2023
Estimated completion1 February 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 70, female only, with Hyperthermic Intraperitoneal Chemotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-center study design, and 30 patients will be enrolled. Eligible patients will receive docetaxel at different dose levels according to the trial schedule.All the enrolled patients were treated with docetaxel during the first HIPEC treatment and cisplatin during the second HIPEC treatment at 43℃ for 1 hour.The dose of docetaxel for patients in the next group was determined according to the incidence of dose-limiting toxicity (DLT) of the previous docetaxel dose level. Finally, the maximum tolerated dose (MTD) of docetaxel for HIPEC was calculated according to the incidence of dose-limiting toxicity.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A phase I dose-finding trial of hyperthermic intraperitoneal docetaxel combined with cisplatin in patients with advanced-stage ovarian cancer.
    You ZY, Wu MF, Li H, Ye YF, et al · · 2024 · cited 4× · PMID 37477105 · DOI 10.3802/jgo.2024.35.e1

Verify or expand the search:

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Trials testing the same drug.

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Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials

Trials by the same sponsor.

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Data sources for this page

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