Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
Recruiting now · Phase 2
Conditions studied: Oral Squamous Cell Carcinoma, Neoadjvant Therapy, Anti-PD-1, Anti-VEGFR
In brief
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.
Key facts
- Study ID
- NCT05069857
- Run by
- Shanghai Jiao Tong University School of Medicine
- People needed
- 46
- Starts
- 2021-09-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2023-11-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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