MedTrace Logo

Study of HS-20093 Versus Gemcitabine in Combination With Docetaxel in Treatment of Osteosarcoma After Previous Second-line Treatment Failure

NCT06935409 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-04-09

No results posted yet for this study

Summary

This is a randomized, controlled, open, multicenter phase III clinical study to evaluate the efficacy and safety of HS-20093 for injection versus gemcitabine in combination with docetaxel in patients with osteosarcoma who have at least second-line treatment failure.

Conditions

Interventions

DRUG

HS-20093

Study participants in the experimental group shall continue to receive HS-20093 by intravenous infusion at a dose of 12.0 mg/kg, once every 3 weeks (Q3W) with a 21-day treatment cycle. Treatment shall continue until objective disease progression (excluding cases of treatment beyond PD or crossover treatment) or until other criteria for termination of study treatment specified in the protocol are met.

DRUG

Gemcitabine combined with docetaxel

Study participants in the control arm will receive gemcitabine in combination with docetaxel. Gemcitabine (1000 mg/m2) will be administered intravenously over approximately 30 minutes on Days 1 and 8 of each 21-day treatment cycle, followed by docetaxel (75 mg/m2) on Day 8, intravenously over approximately 1 hour until objective disease progression or other criteria for treatment discontinuation are met.

Sponsors & Collaborators

  • Hansoh BioMedical R&D Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2026-08-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06935409 on ClinicalTrials.gov