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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05529667
Eligibility Criteria:
Inclusion Criteria:
1. Patients who agreed in writing to the clinical study consent
2. Histologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.
3. FGFs / FGFRs have genetic variation on NGS.
4. Patients whose life expectancy is at least 3 months
5. If the Eastern Cooperative Oncology Group (ECOG) is 0 or 1
6. Measurable or assessable lesion based on RECIST 1.1 scale
7. Must be swallowed, should be able to take oral medication
8. Possible long-term function to receive chemotherapy.
9. Patients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment
Exclusion Criteria:
1. When chemotherapy exceeded the first treatment
2. Patients with multiple cancers
3. Severe hypersensitivity reactions to anti-FGFR2 agents either now or in the past
4. Patients with endocrine metabolic syndrome or history of calcium-phosphate homeostasis
5. Patients with ectopic neoplasm or history of soft tissue, kidney, large intestine, heart, or abdomen
6. Corneal lesions such as bullous keratopathy, corneal erosion, corneal erosion, corneal ulcer, corneal inflammation and keratoconjunctivitis were confirmed by ophthalmic examination
7. Patients with metastasis to the brain or meninges. However, patients who do not have symptoms and do not need treatment can register.
8. Clinically significant digestive system problems that can cause abnormalities in taking or absorbing clinical drugs
9. Patients with uncontrollable or significant cardiovascular disease
10. Patients with systemic infections requiring treatment
11. Patients who were exposed to paclitaxel at or before the taxane
12. If you undergo major surgery within 28 days before enrollment for this trial
13. Patients who received radiotherapy for gastric cancer within 28 days prior to enrollment for this trial. However, the investigation of bone turnover was conducted within 14 days before the registration for this trial
14. If you received general chemotherapy within 14 days of enrollment for this trial
15. Patients who are positive for human immunodeficiency virus (HIV-1) antibody test,
16. HBsAg results positive, HBV viral load greater than 2000 IU / ml (104 copies / ml), or HCV antibody test positive
17. Patients who are pregnant, lactating, or are likely to be pregnant
18. Anemia and hair loss are excluded if previous chemotherapy treatment has toxicity that is not recovered below grade 2.
19. Patients who are judged to have lost their ability to cope with dementia or other comorbid conditions
20. Other Patients who the examiner or the examiner deemed inappropriate for the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05529667
Study Brief:
Protocol Section:
NCT05529667