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RECRUITING
NCT05713578
EARLY_PHASE1

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

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-03-01

Completion Date

2026-12-01

Last Updated

2023-02-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

apantamide+docetaxel+ADT

Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.

DRUG

apantamide+ADT treatment

apantamide+ADT treatment

Locations (1)

Qilu hospital

Jinan, Shandong, China