NCT05121350

A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride capsule	Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
DRUG	Epirubicin	Epirubicin can inhibit the synthesis of DNA and RNA.
DRUG	Arotinib hydrochloride capsule placebo	Placebo of Anlotinib hydrochloride capsule

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-11-16
• Last updated: 2022-02-18

Locations

3 sites across 1 country: China