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
NCT ID: NCT05121350
Last Updated: 2022-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
256 participants
INTERVENTIONAL
2022-03-31
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of TQB2450 Injection and Anlotinib Hydrochloride Capsules to Treat Triple Negative Breast Cancer (TNBC)
NCT03855358
A Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in the Treatment of Recurrent or Metastatic Advanced Endometrial Carcinoma
NCT05121363
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
NCT04405505
Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma
NCT03880695
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
NCT03016819
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arotinib hydrochloride capsule + Epirubicin
Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
Anlotinib hydrochloride capsule
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
Epirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
Placebo + Epirubicin
Placebo combined with epirubicin, 21 days as a treatment cycle
Epirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
Arotinib hydrochloride capsule placebo
Placebo of Anlotinib hydrochloride capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anlotinib hydrochloride capsule
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
Epirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
Arotinib hydrochloride capsule placebo
Placebo of Anlotinib hydrochloride capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALTN-III-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.