NCT05069857 Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
| NCT ID | NCT05069857 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Oral Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2024-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2021-09-01 with a primary completion date of 2024-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Lai-ping Zhong, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT05069857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Oral Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05069857 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05069857 currently recruiting?
Yes, NCT05069857 is actively recruiting participants. Contact the research team at zhonglp@hotmail.com for enrollment information.
Where is the NCT05069857 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05069857 clinical trial?
NCT05069857 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Lai-ping Zhong, MD, PhD at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 46 participants.