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

NCT05121350 Phase 3 UNKNOWN

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

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	256
Start date	2022-03
Completion	2024-06

Conditions

• Soft Tissue Sarcoma

Interventions

• Anlotinib hydrochloride capsule
• Epirubicin
• Arotinib hydrochloride capsule placebo

Primary outcomes

• Progression free survival (PFS) assessed by independent review committees (IRC) — Baseline up to 12 months
  Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first

Countries

China