Recruiting
Phase 2
Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
Condition(s) studied
Oral Squamous Cell CarcinomaNeoadjvant TherapyAnti-PD-1Anti-VEGFR
Investigational drug(s) / intervention(s)
Camrelizumab (anti-PD-1 inhibitor): 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.
Apatinib (anti-VEGFR inhibitor): 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.
Study 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 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
Primary outcome measure(s)
- 2-year disease-free survival rate — 24 months
Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine |
Shanghai |
Shanghai Municipality |
Recruiting |
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