Tyrosine Kinase Inhibitors in the Management of Local Advanced or Metastastic Adenoid Cystic Carcinoma
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.
• Histologically or cytologically confirmed adenoid cystic carcinoma
• Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) taken 2 to 12 months prior to baseline compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.
• Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and who is previously treated with chemotherapy or local treatment (e,g transarterial chemoembolization)
• Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
• 18 years or older
• ECOG performance status 0, 1, 2, 3
• Previous treatment with chemotherapy, loco-regional therapy (e.g chemoembolization) are permitted providing that toxicity has resolved to ≤grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.
• Adequate organ function
• A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
⁃ A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.