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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Epirubicin

Criteria

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.