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

ConditionsOral Squamous Cell CarcinomaNeoadjvant TherapyAnti-PD-1Anti-VEGFR
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Camrelizumab (anti-PD-1 inhibitor)

    Drug

    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)

    Drug

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Neoadjuvant armExperimental treatment 2 interventions
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

2-year disease-free survival rate

Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause.

Time frame
24 months

Secondary outcomes

1

2-year overall survival rate

Overall survival was calculated from the date of randomization to death from any cause.

Time frame
24 months
2

Major pathological response

The major pathological response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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