Adenocarcinoma, Distantly Metastatic Malignant Neoplasm, Head and Neck Carcinoma, Recurrent Disease
Conditions
Keywords
head and neck adenocarcinoma, Anlotinib
Brief summary
This is a non-randomized, phase II, open label study of anlotinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.
Interventions
DRUGAnlotinib
Anlotinib p.o. qd
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed head and neck adenocarcinoma. 2. Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or radiotherapy. 3. Measurable disease per the RECIST criteria. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Provision of written informed consent. 6. Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.
Exclusion criteria
1. Prior treatment with Anlotinib 2. With pleural effusion or ascites, cause respiratory syndrome 3. Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients 4. Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, 5.Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping 6.Symptoms of brain metastases cannot be controlled and treated within less than 2 months 7.severe and failed to controlled diseases 8.Occurred venous thromboembolic events within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS) | up to 24 months |
| Disease Control Rate (DCR) | up to 24 months |
| Overall Survival (OS) | up to 24 months |
Countries
China
Contacts
Primary ContactShengjin Dou
Outcome results
None listed