head and neck tumors
Conditions
Interventions
head and neck tumors:Anlotinib: 12 mg once a day (recommended to be taken on an empty stomach within ± 60 minutes after the infusion of Piamprimab injection). Continuous oral administration for 2 week
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed the informed consent form, compliance OK, cooperate with follow-up; 2. 18-70 years old, male or female; 3. Locally advanced head and neck squamous cell carcinoma confirmed by histopathology; with at least one measurable lesion (RECIST 1.1); the staging of the included patients meets one of the following: any T4 stage; N1-3 with lymph node metastasis; organ function preservation Difficult patients. 4. ECOG score: 0-2 points; expected survival time greater than 6 months; 5. Have not received systemic anti-tumor therapy before; 6. The function of major organs is normal, that is, the following criteria are met: 1) The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): a.HB=90 g/L; b.ANC=1.5×109/L; c.PLT=80×109/L; 2) The biochemical examination shall meet the following standards: a.TBIL60 ml/min (Cockcroft-Gault formula); 3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = the lower limit of normal (50%). 7. Non-sterilized women of childbearing age have a pregnancy test (serum or urine) performed within 7 days before study enrollment, and the result is negative, the subject and male subjects must agree during the study and after the last administration of the study drug 120 Use a highly effective method of contraception during the day. (Non-contraceptive contraceptives are generally recommended).
Exclusion criteria
Exclusion criteria: 1. Previous use of anti-angiogenic drugs such as bevacizumab, ramucirumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, and endotinib or For PD-1, PD-L1 and other related immunotherapy drugs; 2. Medical history and comorbidities 1) The patient is participating in other clinical studies or less than 4 weeks from the end of the previous clinical study; 2) Patients who have developed or currently have other active malignant tumors within 5 years; patients with basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer who have undergone possible curative treatment and have no disease recurrence within 5 years after the start of treatment except; 3) Received external beam radiation therapy within the past 3 months or unplanned systemic anti-tumor therapy during the study drug period, including cytotoxic therapy, signal transduction inhibitors (or within 6 weeks before receiving the experimental drug treatment) Mitomycin C), can not use traditional Chinese medicine anti-tumor treatment at the same time. 4) Imaging (CT or MRI) shows that the tumor invades the large blood vessels or the boundary with the blood vessels is unclear; 5) Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/day prednisone or other equivalent therapeutic hormones), and still within 2 weeks before the first dose continue to use; 6) Uncontrolled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg despite optimal medical treatment); 7) Patients whose adverse reactions (except hair loss) caused by any previous treatment have not recovered to NCI-CTCAE4.0 = grade 2; 8) Abnormal coagulation function (prothrombin time international normalized ratio (INR)>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with bleeding tendency or receiving thrombolysis or anticoagulation therapy ; Note: On the premise of INR=1.5, the use of low-dose heparin (daily dose of 6,000-12,000 U for adults) or low-dose aspirin (daily dose = 100 mg) for prevention is allowed; 9) Renal insufficiency: urine routine indicates urine protein = ++, or confirmed 24-hour urine protein amount = 1.0g; 10) Received major surgical operations 28 days before enrollment; long-term unhealed wounds or fractures; 11) According to the NCI-CTCAE 5.0 grading standard, patients with pleural effusion or pneumothorax of grade 3 or above; 12) Severe acute or chronic infections requiring systemic treatment; 13) Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval =450 ms for males and =470 ms for females); according to NYHA standards, grades III to IV cardiac arrhythmias Insufficiency, or echocardiography showed left ventricular ejection fraction (LVEF) 10mmol/ml); 16) There are factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 17) Significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as respiratory bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above at baseline, or suffering from vascular disease Inflammation, etc.; imaging shows that the tu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Progression Free Survival (PFS);Disease Control Rate (DCR); | — |
Contacts
Public ContactHui Liu
Fujian Cancer Hospital
Outcome results
None listed