Oral Squamous Cell Carcinoma Clinical Trial
Official title:
Neoadjuvant Personalized Anti-PD-1 Therapy With Combination of Anti-VEGFR Therapy in Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Randomized Controlled Phase II Trial
To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS>10 in the biopsy samples.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | June 30, 2028 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age: 18 to 75 2. Gender: Male and female 3. ECOG Score: 0-2 4. Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area) 5. Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th) 6. The combined positive score (CPS score) of PD-L1 expression > 10 7. Has signed informed consent Exclusion Criteria: 1. Toxicity of = grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy 2. Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, = grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment) 3. Active severe clinical infection (> NCI-CTCAE Version 5.0 level 2 infection) 4. Uncontrollable hypertension (systolic blood pressure > after antihypertensive medication; 150mmHg and/or diastolic blood pressure > 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as cerebrovascular accident (= 6 months before screening), myocardial infarction (= 6 months before screening), unstable angina, congestive heart failure rated class II or above by NYHA, or severe arrhythmias that cannot be controlled or have a potential impact on trial treatment 5. Blood routine examination: WBC < 3,000/mm3, hemoglobin < 8g/L, platelet < 80,000/mm3 6. Liver function: ALAT/ASAT > 2.5 times the normal upper limit, bilirubin > 1.5 times the normal upper limit 7. Renal function: serum creatinine > 1.5 times the normal upper limit 8. Has a history of maxillofacial and neck radiotherapy 9. Pregnant or lactating women 10. Participation in other clinical studies within 30 days prior to enrollment 11. Other conditions that the investigator considers inappropriate for participation |
Country | Name | City | State |
---|---|---|---|
China | Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year disease-free survival rate | Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause. | 24 months | |
Secondary | 2-year overall survival rate | Overall survival was calculated from the date of randomization to death from any cause. | 24 months | |
Secondary | Major pathological response | The major pathological response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as = 10% RVT%. | 3 months |
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