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
Overview
- Phase
- Phase 3
- Intervention
- Anlotinib hydrochloride capsule
- Conditions
- Soft Tissue Sarcoma
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 256
- Locations
- 3
- Primary Endpoint
- Progression free survival (PFS) assessed by independent review committees (IRC)
- Last Updated
- 4 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy \>=3 months.
- •Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
- •Understood and signed an informed consent form.
Exclusion Criteria
- •Diagnosed and/or treated additional malignancy within 5 years before the first dose.
- •With factors affecting oral medication.
- •Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.
- •A history of psychotropic drug abuse or have a mental disorder.
- •Any severe and/or uncontrolled diseas.
- •Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose.
- •Has participated in other clinical studies within 4 weeks before the first dose.
- •According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
Arms & Interventions
Arotinib hydrochloride capsule + Epirubicin
Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
Intervention: Anlotinib hydrochloride capsule
Arotinib hydrochloride capsule + Epirubicin
Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
Intervention: Epirubicin
Placebo + Epirubicin
Placebo combined with epirubicin, 21 days as a treatment cycle
Intervention: Epirubicin
Placebo + Epirubicin
Placebo combined with epirubicin, 21 days as a treatment cycle
Intervention: Arotinib hydrochloride capsule placebo
Outcomes
Primary Outcomes
Progression free survival (PFS) assessed by independent review committees (IRC)
Time Frame: 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
Secondary Outcomes
- Overall survival (OS)(Baseline up to die)
- progression free survival (PFS) assessed by investigator(Baseline up to 12 months)
- Objective response rate (ORR)(Baseline up to 6 months)
- Disease control rate (DCR)(Baseline up to 25 months)
- Duration of overall response (DOR)(Baseline up to 6 months)
- Degradation rate(Baseline up to 6 months)