Clinical trial NCT05121350: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Soft Tissue Sarcoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-16
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Progression free survival (PFS) assessed by independent review committees (IRC)
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Baseline up to die
measure: progression free survival (PFS) assessed by investigator
timeFrame: Baseline up to 12 months
measure: Objective response rate (ORR)
timeFrame: Baseline up to 6 months
measure: Disease control rate (DCR)
timeFrame: Baseline up to 25 months
measure: Duration of overall response (DOR)
timeFrame: Baseline up to 6 months
measure: Degradation rate
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
Study officials:
References: