Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients

Launched by SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Sep 25, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with locally advanced oral squamous cell carcinoma (OSCC), a type of mouth cancer. The study is looking at the effectiveness of combining two medications, anti-PD-1 and anti-VEGFR, given before surgery to see if this can help shrink the tumors and improve outcomes for patients. To be eligible for this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of OSCC, and show certain markers in their biopsy samples that suggest they might benefit from this treatment.

Participants in this trial can expect to receive the combination therapy for a specific period before they undergo surgery to remove the cancer. They will be closely monitored by the medical team throughout the trial to ensure their safety and to assess how well the treatment is working. It's important to know that patients with certain health issues, such as severe heart or blood problems, or those who are pregnant or breastfeeding, may not be eligible to participate. This trial aims to provide valuable insights into how we can better treat this type of cancer and improve the lives of those affected by it.

Gender

ALL

Eligibility criteria

• 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