Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
single arm:Sintilimab combined with Anlotinib
Sponsors
He' nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed recurrent / metastatic head and neck squamous cell carcinoma who are not suitable for local treatment (radiotherapy or surgery); 2. Patients who failed to receive first-line chemotherapy or chemotherapy combined with cetuximab; 3. Patients over 18 years old; 4. Patients with expected survival time >=12 weeks; 5. According to RECIST v1.1, there was at least one measurable or evaluable lesion; 6. Patients with ECoG PS score of 0-2 according to the eastern cancer collaboration group; 7. Having adequate organ and bone marrow function, defined as follows: (1) Blood routine examination: absolute neutrophil count >=1.5x10^9/L; platelet count >=100x10^9/L; hemoglobin content >=9.0 g/dl; (2) Liver function: serum total bilirubin (TBIL) =50ml/min; urine test results showed that urinary protein < 2 +; (4) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 ULN; 8. Patients who need 2 weeks of washout from the front-line chemotherapy or targeted therapy need 4 weeks interval from the previous radiotherapy.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods; 2. Patients who have previously used PD-1 antibody drugs or anlotinib; 3. Patients who are allergic to sindili or anlotinib; 4. Patients with high risk of bleeding or perforation due to tumor invasion of the great artery or trachea, or patients with fistula; 5. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe lung function impairment and other lung diseases; 6. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period; 7. Patients with active, known or suspected autoimmune diseases; 8. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. Untreated patients with acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions; 10. Uncontrolled concurrent diseases include but are not limited to: (1) HIV infected (HIV antibody positive); (2) Severe infection in active stage or poorly controlled; (3) Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]); (4) Patients with active bleeding or new thrombotic disease who are taking anticoagulant drugs or have bleeding tendency; 11. According to the judgment of the researchers, there are patients with accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DCR;AE;QoL; | — |
Countries
China
Contacts
Public ContactWang Chaojie
He'nan Provincial People's Hospital
Outcome results
None listed