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
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Registration Number
- NCT05121350
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 256
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Epirubicin Arotinib hydrochloride capsule placebo Placebo combined with epirubicin, 21 days as a treatment cycle Arotinib hydrochloride capsule + Epirubicin Anlotinib hydrochloride capsule Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle Arotinib hydrochloride capsule + Epirubicin Epirubicin Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle Placebo + Epirubicin Epirubicin Placebo combined with epirubicin, 21 days as a treatment cycle
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Baseline up to die From randomization to the time of death from any cause
progression free survival (PFS) assessed by investigator Baseline up to 12 months Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
Objective response rate (ORR) Baseline up to 6 months The sum of percentage of participants with complete response rate and partial response rate
Disease control rate (DCR) Baseline up to 25 months percentage of participants with complete response, partial response plus stable disease
Duration of overall response (DOR) Baseline up to 6 months the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression
Degradation rate Baseline up to 6 months Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period
Trial Locations
- Locations (3)
Fudan University Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Beijing Jishuitan Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China