Overview
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
Eligibility
Inclusion Criteria:
- 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.
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.