Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
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
Shanghai Jiao Tong University School of Medicine
46 participants
Sep 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Age: 18 to 75
- Gender: Male and female
- ECOG Score: 0-2
- Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
- Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
- The combined positive score (CPS score) of PD-L1 expression \> 10
- Has signed informed consent
Exclusion Criteria11
- Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy
- 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)
- Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
- 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
- Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
- Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
- Renal function: serum creatinine \> 1.5 times the normal upper limit
- Has a history of maxillofacial and neck radiotherapy
- Pregnant or lactating women
- Participation in other clinical studies within 30 days prior to enrollment
- Other conditions that the investigator considers inappropriate for participation
Interventions
The patients will receive three cycles of Camrelizumab, with 14 days each. 200mg of Carrelizumab will be used intravenously on the first day of each cycle.
The patients will receive Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle.
Locations(1)
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NCT05069857