Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT05121350
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05121350
Study Brief:
Protocol Section:
NCT05121350