oral squamous cell carcinoma
Conditions
Interventions
Immunotherapy and targeted treatment :Anlotinib: 12mg/d, Q3W, subjects take Anlotinib orally every day for two weeks and stop for one week
Pembrolizumab Injection or Penpulimab Injection: 200mg, IVgtt
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate in this study and sign the informed consent form, with good compliance and cooperation in follow-up; 2.Aged over 18 years old, gender not limited; 3.Patients with locally advanced oral cancer (stages III-IVb) diagnosed pathologically, with negative surgical margins and CPS>=1; 4.Patients deemed by the researcher to be eligible for R0 surgery, with the primary lesion without surgery or radiotherapy; 5.At least one measurable lesion (RECIST 1.1); 6.ECOG score: 0-1 points; Life expectancy greater than 6 months; 7.No previous systemic anti-tumor treatment; 8.Normal function of major organs, meeting the following criteria: 9.Hematological examination standards must be met (within 14 days without blood transfusion and blood products, and without correction with G-CSF and other hematopoietic growth factors): a. Hb>=90 g/L; b. ANC>=1.5×10^9/L; c. PLT>=80×10^9/L; 10.Biochemical examination must meet the following criteria: a. TBIL 60 ml/min (Cockcroft-Gault formula); 11.Doppler echocardiographic assessment: Left ventricular ejection fraction (LVEF) >= lower limit of normal (50%). 12.Non-sterilized women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before entering the study, and the result must be negative, and they must be willing to use appropriate methods of contraception during the trial period and within 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate methods of contraception during the trial period and within 8 weeks after the last administration of the trial medication or have undergone surgical sterilization.
Exclusion criteria
Exclusion criteria: 1.Have received treatment with anti-angiogenic drugs (such as sunitinib, sorafenib, regorafenib, bevacizumab, imatinib, apatinib, etc.); 2.Primary lesion with deep ulcer; with necrotic lesions, or primary lesion have a risk of bleeding from the tumor adjacent to important vessels as assessed by the investigator; 3.Significant clinical bleeding symptoms within three months prior to enrollment or a clear tendency to bleed; 4.Patients are currently participating in other clinical studies or the time since the end of the previous clinical study treatment is less than 4 weeks; 5.Other active malignant tumors within 5 years or currently coexisting; 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 are excluded; 6.Received radiotherapy within the last 3 months or plan to undergo systemic anti-tumor treatment during the study medication period, including cytotoxic therapy, signal transduction inhibitors (or used mitomycin C within 6 weeks before receiving the trial drug treatment), and cannot use traditional Chinese medicine anti-tumor treatment at the same time. 7.Uncontrolled hypertension (systolic blood pressure >=150 mmHg or diastolic blood pressure >= 100 mmHg, despite optimal medical treatment); 8.Patients whose adverse reactions from any previous treatment (except for hair loss) have not recovered to 1.5 or Prothrombin Time (PT) >ULN+4 seconds or APTT >1.5 ULN), with a tendency to bleed or currently undergoing thrombolytic or anticoagulant treatment; Note: The use of low-dose heparin for preventive purposes is allowed (adult daily dosage of 6,000 to 12,000 U) or low-dose aspirin (daily dosage = ++, or confirmed 24-hour urinary protein quantity >=1.0g; 11.Received major surgical operations within 28 days before enrollment; long-term unhealed wounds or fractures; 12.Patients with grade 3 or higher pleural effusion or pneumothorax according to the NCI-CTCAE 5.0 grading standard; 13.Severe acute or chronic infections requiring systemic treatment; 14.Patients with severe cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval for men >=450 ms, women >=470 ms); Grade III to IV heart failure according to NYHA standards, or echocardiography indicating left ventricular ejection fraction (LVEF) = grade 2 according to CTCAE, excluding those caused by trauma; 16.Poorly controlled diabetes (fasting blood glucose >10 mmol/ml); 17.Factors that significantly affect the absorption of oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 18.Significant clinical bleeding symptoms within 3 months before enrollment or a clear tendency to bleed, such as respiratory tract bleeding, gastrointestinal bleeding, bleeding gastric ulcers, baseline stool occult blood ++ or higher, or patients with vasculitis; Imaging shows that the tumor has invaded the surrounding of important blood vessels or the researcher judges that the tumor is very likely to invade important blood vessels during the subsequent study per
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate at 2 years after surgery;1 year Overall Survival;3 years Overall Survival;The 1-year recurrence rate of patients with locally advanced oral cancer after adjuvant target therapy; | — |
Countries
China
Contacts
Public ContactAnxun Wang
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed