Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Sintilimab + Anlotinib
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood and signed the informed consent form for this study; 2. Patients with histologically and/or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck. Patients with metastatic head and neck squamous cell carcinoma who have failed one or more prior platinum-based chemotherapy (chemotherapy) and patients with local recurrence who are not suitable for local therapy or radical therapy. For subjects who previously received neoadjuvant chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy, if there is recurrence or metastasis within 6 months after the end of the last treatment, this study can be conducted; 3. At least one measurable lesion (according to RECIST1.1), lesions that have received radiotherapy can be considered as target lesions if progression is confirmed by imaging judgment; 4.ECOG score 0-1; 5.Aged 18 to 70 years; 6.Expected survival >= 3 months; 7.Laboratory values within 7 days before enrollment must meet the following criteria (no administration of any blood component, cell growth factor, albumin or other corrective treatment is allowed before 14 days after laboratory tests are obtained): a:Hematological examination:neutrophils >= 1.5 x 10^9/L, hemoglobin >= 90 g/L, platelets >= 75 x 10^9/L;b:liver function: ALT, AST = 2 +, 24-hour urine collection should be performed and 24-hour urine protein quantification < 1g; 9. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times of the upper limit of normal; 10. Female patients of childbearing age or male patients with sexual partners of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after medication.
Exclusion criteria
Exclusion criteria: 1. Patients with head and neck adenocarcinoma or nasopharyngeal squamous cell carcinoma were > 70 years old or 10 mg/day or other effective hormones) for more than 4 weeks can be included; 8. Subjects are found to have necrotic lesions on examination within 4 weeks before enrollment, and are judged to have a risk of massive hemorrhage by the investigator; 9. Previous or current other malignancies (except effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past 5 years); 10. Subjects with any active autoimmune disease or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood, without any intervention after adulthood can be included; subjects with asthma requiring bronchodilator medical intervention can not be included); 11. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 or anti-CTLA-4 drugs (or any other antibody acting on T cell costimulation or checkpoint pathway); 12. Subjects with active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or receiving anti-tuberculosis treatment within 1 year before screening; 13. Patients with complications requiring long-term use of immunosuppressive drugs, or requiring systemic or local use of immunosuppressive doses of corticosteroids; 14. Received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment; 15. Pregnant or lactating women; 16. HIV-positive; 17. Acute or chronic active hepatitis B or C infection, Hepatitis B virus (HBV) DNA > 20001U/ml or 104 copies/ml, hepatitis C virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Duration of Response;Time to Response; | — |
Countries
China
Contacts
Public ContactJianWu Ding
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed