RecruitingPhase 2NCT05069857

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

Neoadjuvant Personalized Anti-PD-1 Therapy With Combination of Anti-VEGFR Therapy in Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Randomized Controlled Phase II Trial


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

46 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two immunotherapy drugs — one that targets PD-1 (a brake on the immune system) and one that blocks blood vessel growth — before surgery in people with mouth cancer. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with oral squamous cell carcinoma (cancer of the mouth, tongue, or gums) at stage III or IVA - Your cancer's PD-L1 score (a measure of immune activity) is greater than 10 - Your cancer has not been treated with radiation to the head or neck before - Your general health is good enough to handle treatment (ECOG score 0–2) **You may NOT be eligible if...** - You have serious heart problems, a recent heart attack, or uncontrolled high blood pressure - You have a serious active infection - Your blood counts, liver, or kidney tests are abnormal - You are pregnant or breastfeeding - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab (anti-PD-1 inhibitor)

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.

DRUGApatinib (anti-VEGFR inhibitor)

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.


Locations(1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT05069857


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