Soft Tissue Sarcoma
Conditions
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
Interventions
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
DRUGEpirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
DRUGArotinib hydrochloride capsule placebo
Placebo of Anlotinib hydrochloride capsule
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactShanghai Niu, Bachelor
Backup ContactYUHONG ZHOU, Doctor
Outcome results
None listed