Personalized anti-PD-1 and anti-VEGFR therapy for oral cancer 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
This study is testing a personalized treatment combining two medications for patients with advanced oral cancer to see if it helps them stay cancer-free for longer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | Carrelizumab, Apatinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05069857 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed primary oral squamous cell carcinoma and a CPS score greater than 10.
Not a fit: Patients with severe cardiovascular issues, uncontrolled hypertension, or significant infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced oral squamous cell carcinoma.
How similar studies have performed: Previous studies using similar neoadjuvant therapies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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 — Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Lai-ping Zhong, MD, PhD
- Email: zhonglp@hotmail.com
- Phone: +862123271699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.