drugset
drugset / Trial / NCT05713578

Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study

NCT05713578 ↗

Phase 0 Recruiting 220 enrolled Qilu Hospital of Shandong University
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan:Treatment group 1: apantamide+docetaxel+ADT,Treatment group 2: apantamide+ADT treatment.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Timeline

Start
2023-03-01
Primary completion
2026-02-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject apantamide Unknown 240 mg Oral

Indications

No indication recorded.