Last updated: February 16, 2022
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Soft Tissue Sarcoma
Sarcoma
Sarcoma (Pediatric)
Treatment
N/AClinical Study ID
NCT05121350
ALTN-III-04
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 duringthe study period and for at least 6 months after study is stopped; male patientsshould agree to use contraception during the study period and for at least 6 monthsafter study is stopped.
- Understood and signed an informed consent form.
Exclusion
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 4weeks 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 weeksbefore 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 subjectsare not suitable for the study.
Study Design
Total Participants: 256
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2024
Connect with a study center
Beijing Jishuitan Hospital
Beijing, Beijing 100032
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Fudan University Zhongshan Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting
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