Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Camrelizumab (anti-PD-1 inhibitor)
- Apatinib (anti-VEGFR inhibitor)
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov