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A Dose-finding Trial of Hyperthermic Intraperitoneal Docetaxel

NCT05410483 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-08

No results posted yet for this study

Summary

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.

Conditions

  • Hyperthermic Intraperitoneal Chemotherapy

Interventions

DRUG

Docetaxel

Hyperthermic Intraperitoneal Docetaxel

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Zhongqiu Lin · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410483 on ClinicalTrials.gov