Personalized anti-PD-1 and anti-VEGFR therapy for oral cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a personalized treatment combining anti-PD-1 and anti-VEGFR therapies for patients with locally advanced and resectable oral squamous cell carcinoma (OSCC) who have a combined positive score (CPS) greater than 10. Participants will receive three cycles of Camrelizumab and Apatinib before undergoing standard surgical treatment and postoperative therapy. The primary goal is to assess the 2-year disease-free survival rate among participants. Previous trials indicated promising results, with a significant proportion of patients achieving major pathological response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18 to 75
2. Gender: Male and female
3. ECOG Score: 0-2
4. Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
5. Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
6. The combined positive score (CPS score) of PD-L1 expression \> 10
7. Has signed informed consent

Exclusion Criteria:

1. Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy
2. 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)
3. Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
4. 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
5. Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
6. Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
7. Renal function: serum creatinine \> 1.5 times the normal upper limit
8. Has a history of maxillofacial and neck radiotherapy
9. Pregnant or lactating women
10. Participation in other clinical studies within 30 days prior to enrollment
11. Other conditions that the investigator considers inappropriate for participation

Where it's running

• Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Lai-ping Zhong, MD, PhD — Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Lai-ping Zhong, MD, PhD
• Email: zhonglp@hotmail.com
• Phone: +862123271699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.