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:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT04472858
Eligibility Criteria:
Inclusion Criteria:
* Fully understand this study and voluntarily sign ICF;
* 18 to 75 years old (including 18 and 75 years old), male or female;
* Subjects with advanced solid tumors, including:
Phase I study:
subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.
Exclusion Criteria:
* Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included;
* Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
* Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter;
* Human immunodeficiency virus (HIV) antibody positive;
* Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;
* Lactating women. If they are willing to stop breastfeeding, they can also be included in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04472858
Study Brief:
Protocol Section:
NCT04472858