Oral squamous cell carcinoma
Conditions
Interventions
Experimental group:This study first administers two cycles of neoadjuvant (targeted immunotherapy + chemotherapy) treatment, with the medication discontinued two weeks prior to surgery.
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in this study and signed the informed consent form. They had good compliance and cooperated with the follow-up. 2. Age range: 18-70 years old, gender not restricted. 3. Patients with locally advanced oral cancer (stage III-IVa), including oral cancer and oropharyngeal cancer, diagnosed by pathology. 4. Those determined by the investigators to be suitable for surgical treatment or potentially operable, with the primary lesion not undergoing surgery or radiotherapy. 5. At least one measurable lesion (according to RECIST 1.1). 6. ECOG score: 0-1; Expected survival period greater than 6 months. 7. No previous systemic anti-tumor treatment. 8. Normal function of major organs. 9. Blood routine examination criteria need to meet (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction): a. HB >= 90 g/L; b. ANC >= 1.5 × 10^9/L; c.PLT>=80×10^9/L 10. The biochemical tests must meet the following criteria: a. TBIL 60 ml/min (Cockcroft-Gault formula) 11. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%) 12. Non-sterilized women of childbearing age should undergo a pregnancy test (serum or urine) within 7 days before the study enrollment, and the result should be negative. They should also be willing to use appropriate methods of contraception during the trial and within 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception during the trial and within 8 weeks after the last administration of the trial drug or have undergone sterilization surgery.
Exclusion criteria
Exclusion criteria: 1. Have received treatment with anti-angiogenic drugs (such as sunitinib, sorafenib, regorafenib, bevacizumab, imatinib, apatinib, etc.) 2. Have deep ulcers; have necrotic lesions, or have been evaluated by the investigator as having a risk of bleeding adjacent to important blood vessels 3. Experienced significant clinically significant bleeding symptoms within the previous three months or had a clear bleeding tendency 4. The patient is participating in other clinical studies or the time since the end of the previous clinical study is less than 4 weeks 5. Has developed or currently has other active malignant tumors within 5 years; has undergone possible curative treatment for skin basal cell carcinoma, superficial bladder cancer, or in situ cervical cancer and has no disease recurrence within 5 years after the start of the treatment, except for patients who have undergone possible curative treatment and have no disease recurrence within 5 years after the start of the trial drug treatment 6. Has received external radiotherapy within 3 months or plans to undergo systemic anti-tumor treatment outside of this study, including cytotoxic therapy, signal transduction inhibitors (or used mitomycin C within 6 weeks before the trial drug treatment), and cannot use traditional Chinese medicine for anti-tumor treatment simultaneously 7. Has uncontrollable hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg, despite the best drug treatment) 8. Any adverse reactions caused by previous treatment (except for hair loss) have not recovered to NCI-CTCAE 5.0 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5 ULN), has a bleeding tendency or is undergoing thrombolytic or anticoagulant treatment; Note: Under the condition of INR = ++, or confirmed 24-hour urine protein quantity >= 1.0 g 11. Received major surgical procedures within the previous 28 days; long-term unhealed wounds or fractures 12. According to the NCI-CTCAE 5.0 grading standard, patients with grade 3 or above pleural effusion or pneumothorax 13. Severe acute or chronic infections requiring systemic treatment 14. Have severe cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval for males >= 450 ms, females >= 470 ms); According to the NYHA standard, grade III - IV cardiac insufficiency, or echocardiography indicates left ventricular ejection fraction (LVEF) = CTCAE 2 degree peripheral neuropathy, excluding trauma-induced 16. Poorly controlled diabetes (fasting blood glucose > 10 mmol/ml) 17. Has significant factors affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc. 18. Experienced significant clinically significant bleeding symptoms or had a clear bleeding tendency within the previous 3 months, such as respiratory tract bleeding, gastrointestinal bleeding, bleeding gastric ulcer at baseline with stool occult blood ++ or above, or having vasculitis; Imaging shows that the tumor has invaded t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival period;Postoperative disease control rate;Removal rate of R0;One-year local recurrence-free survival rate;One-year survival rate without distant metastasis;Safety; | — |
Countries
China
Contacts
Public ContactAnxun Wang
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed