Clinical trial · Interventional
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
NCT05069857CI-TRIAL-00071587recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-PD-1 | — | UNRESOLVED | — |
| Anti-VEGFR | — | UNRESOLVED | — |
| Neoadjvant Therapy | — | UNRESOLVED | — |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib (anti-VEGFR inhibitor) | Drug | — | UNRESOLVED |
| Camrelizumab (anti-PD-1 inhibitor) | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant arm
- description
- The patients received three cycles of neoadjuvant therapy, with 14 days each. Dosage and administration: 200mg Carrelizumab intravenously on the first day of each cycle; Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle. Then the patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
- interventionNames
- Drug: Camrelizumab (anti-PD-1 inhibitor)
- Drug: Apatinib (anti-VEGFR inhibitor)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- The patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
Primary outcomes (1)
- measure
- 2-year disease-free survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.