Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients (NCT05069857) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
China46 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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 criteria
✕. 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
What they're measuring
1
2-year disease-free survival rate
Timeframe: 24 months
Trial details
NCT IDNCT05069857
SponsorShanghai Jiao Tong University School of Medicine