head and neck squamous cell carcinoma
Conditions
Interventions
Group 1 :penpulimab combined with anlotinib and albumin paclitaxel
Sponsors
Qingdao Municipal Hospital East Branch
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. The ECOG score is 0-1, and the expected survival time is more than 3 months; 3. Patients with recurrent or metastatic head and neck squamous cell carcinoma diagnosed by histology or cytology or recurrent head and neck squamous cell carcinoma with clear pathology in the past, including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasal cavity and Paranasal sinus squamous cell carcinoma, etc., but nasopharyngeal carcinoma is excluded; 4. Patients with local recurrence or distant metastasis who cannot receive radical treatment (including radiotherapy and surgery); 5. Patients who have not received systemic treatment for local recurrence or distant metastasis; 6. Taxane chemotherapy drugs have been used during radical concurrent radiotherapy and chemotherapy in the past, and the interval between the time of enrollment and the last chemotherapy is required to be > 6 months; 7. Patients who have used cetuximab or nimotuzumab during previous radical radiotherapy can be enrolled; 8. Patients with bone metastases can be enrolled (except for patients with severe bone adverse events such as spinal cord compression); 9. The patient has measurable lesions defined by the RECIST 1.1 standard; 10. The main organ function is good, and the laboratory test indicators meet: (1) Blood routine examination (no blood transfusion, no use of hematopoietic stimulating factors within 7 days before screening): 1) Hemoglobin (HB) >= 90 g/L; 2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; 3) Platelets (PLT) >= 90 x 10^9/L; (2) Blood biochemical examination (no blood or albumin transfusion within 7 days before screening): 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 ml/min; (3) Coagulation function test: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%; (5) Thyroid function indicators: Thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range; if TSH is not within the normal range, FT3/FT4 within the normal range can be included in the group; 11. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days before study enrollment, and must be a non-lactating patient, or meet one of the following criteria to prove that there is no risk of pregnancy: (1) Postmenopause is defined as being older than 50 years and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy; (2) For women younger than 50 years old, if they have been amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also considered postmenopausal; (3) Has received irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, except bi
Exclusion criteria
Exclusion criteria: 1. Head and neck squamous cell carcinoma patients with active bleeding within 2 months of the primary lesion; 2. Brain metastases with symptoms or symptom control time less than 4 weeks; 3. Hypersensitivity to pembrolizumab, anlotinib raw materials and excipients; 4. Have received the following treatments in the past: anti-angiogenic drugs such as anlotinib; anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or other drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA- 4, OX-40, CD137); 5. People with multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 6. Patients with head and neck squamous cell carcinoma who cannot receive chemotherapy or cannot tolerate chemotherapy; 7. Patients with any severe and/uncontrolled diseases, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >= 430 ms) and grade I cardiac insufficiency (New York Heart Association (NYHA) functional class); (2) Active or uncontrolled severe infection; (3) Liver diseases such as cirrhosis, decompensated liver disease, and chronic active hepatitis; (4) Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); (5) Urine routine prompts urine protein >= ++, and confirmed 24-hour urine protein quantity > 1.0 g; 8. Long-term unhealed wounds or fractures; 9. Pulmonary hemorrhage with NCICTCAE V5.0 grade > grade 1 within 4 weeks before enrollment; bleeding in other parts with NCICTCAE V5.0 grade > grade 2 within 4 weeks before enrollment; bleeding tendency (such as active peptic ulcer) or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 10. Received major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks before the first dose of the study or expected to need major surgery during the study treatment; 11. History of gastrointestinal perforation and/or fistula occurred within 6 months before the selected treatment; or excessive arterial/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Imaging studies show that the tumor has invaded important blood vessels or the researchers judged that the tumor is very likely to invade important blood vessels during the follow-up study and cause fatal massive hemorrhage; 13. Ascites with clinical significance, including any ascites that can be found in physical examination, ascites that has been treated before or still needs treatment, and those who only have a small amount of ascites but are asymptomatic on imaging can be selected; 14. Patients with moderate amount of pleural effusion in both sides, or a large amount of pleural effusion in one side, or patients who have caused respiratory dysfunction and need drainage; 15. Known to have active pulmonary tuberculosis; 16. Suffering from interstitial lung disease requiring steroid hormone therapy; 17. Uncontrolled metabolic disorders or other non-malignant tumor organ or systemic diseases or secondary reactions to cancer, which can lead to higher medical risks and/or uncertainty in survival evaluation; 18. Significant malnutrition, such as the need for intravenous nutriti
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Progression-free survival, PFS;Remission time;safety;Overall survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactMi Zhou
Qingdao Municipal Hospital East Branch
Outcome results
None listed