A Phase 2 interventional study of EGFR-TK Inhibitor in Carcinoma, Adenoid Cystic, sponsored by Qingdao Central Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Qingdao Central Hospital · Phase 2, Interventional, and Treatment
There is no clinical study on epidermal growth factor receptor tyrosine kinase inhibitors has been systematically conducted in adenoid cystic carcinoma.
This is a phase II study EGFR TKIs in adenoid cystic carcinoma to evaluate its efficacy in this disease.
The histologic appearance of adenoid cystic carcinoma is low grade, management of this malignancy is a challenge because of its insidious local growth pattern and lack of effency with chemotherapy or radiotherapy in metastatic disease.
In other performed clinical trials, objective responses to any cytotoxic agent or regimen are infrequent, whereas stabilization of disease was observed more commonly.
In adenoid cystic carcinoma, the study focusing on EGFR pathway is rare. According to previous study, adenoid cystic carcinoma cell lines have increased pAkt activity when EGF-stimulation is added. And when treated with EGFR/VEGFR TK dual inhibitor, the phosphorylated form of Akt decreased despite of total level of Akt is remained unchanged.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Qingdao Central Hospital is the lead sponsor of 23 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A patient with no measurable disease, or allergy to the EGFR TKIs 2. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry) 4. A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding 5. A pregnant or lactating patient 6. A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential) 7. A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study 9. A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
EGFR TKIs
Drug: EGFR-TK Inhibitor
epidermal growth factor receptor tyrosine kinase inhibitors
progression free survival
progression free survival
Time frame: 10 months
overall survival
overall survival
Time frame: 2 years
Plan to share: No
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Qingdao Central Hospital