KCT0007702
Recruiting
未知
A phase II trial of neoadjuvant nivolumab, docetaxel, cisplatin therapy followed by surgery and radiation therapy for resectable high grade salivary gland carcinoma
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex: Male or female.
- •2\. Age (at the time of informed consent): 19 years and older.
- •3\. Subjects with histologically\- or cytologically\-confirmed resectable, clinically node\-positive high grade salivary gland carcinoma.
- •\- Adenoid cystic carcinoma: Tubular/cribriform pattern predominant, Solid pattern \> 30%
- •\- Poorly differentiated carcinoma
- •\- Mucoepidermoid carcinoma, High grade
- •\- Polymorphous adenocarcinoma, High grade
- •\- Lymphoepithelial carcinoma
- •\- Salivary duct carcinoma
- •\- Adenocarcinoma, NOS, High grade
Exclusion Criteria
- •1\. Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (eg, CTLA\-4, OX 40, CD137\).
- •2\. Has received prior systemic anti\-cancer therapy including investigational agents except patient had no active treatment for past 5 years.
- •3\. Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular\-targeted therapy agents, or immunotherapy agents) for high\-grade SGC before the first dose of the investigational product.
- •4\. Has received prior radiotherapy.
- •5\. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub\-investigator.
- •6\. Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease.
- •7\. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment.
- •8\. Patients with pericardial fluid, pleural effusion, or ascites requiring treatment.
- •9\. Patients who have experienced a transient ischemic attack, cerebrovascular accident, or thrombosis within 180 days before enrollment.
- •10\. Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
Outcomes
Primary Outcomes
Not specified
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