Clinical trial · Observational
Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
NCT05578170CI-TRIAL-00063644PROBESunknownClinicalTrials.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)
The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. The primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (pTR-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections \> 50%). The secondary endpoints are 1-year disease-free survival (DFS), 1-year overall survival (OS) and the incidence of adverse events, compared with historical data. In addition, we will check the relevant immune indicators, such as PD-L1 and CPS scores.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Pembro Neoadjuvant + SOC Adjuvant
- interventionNames
- Drug: Pembrolizumab
Primary outcomes (1)
- measure
- Rate of pathologic tumor response-2（pTR-2）
- timeFrame
- Up to 30 days post-sugery
- description
- The proportion of participants with a pathologic tumor response-2（pTR-2）as assessed by the Central Pathologist at the time of definitive surgery. pTR-2 is defined as the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections \> 50%
Secondary outcomes (3)
- measure
- Disease-free Survival (DFS)
- timeFrame
- Up to 1 year
- description
- DFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 * Male and female * Patients histologically or cytologically difined as oral cavity squamous cell carcinoma * According to the American Joint Committee on Cancer ( AJCC 8th Edition ) , patients with resectable stage III-IVA OCSCC * ECOG performance status ≤ 1 * Patients with normal bone marrow and organ function as defined below: Blood routine examination: 1. Absolute neutrophil count ≥ 1.5×109/L; 2. Platelets ≥ 100.0×109/L; 3. Hemoglobin ≥ 9.0 g/dL. Liver function: 1. Totle bilirubin ≤ 2.0×ULN(Upper Limit Of Normal); 2. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase * 2.5×ULN; 3. Albumin ≥ 2.8g/dL. Renal function: (1)Creatinine clearance rate \> 60.0ml/min. Coagulation function: (1)International Normalized Ratio ≤ 1.5；Activated Partial Thromboplastin Time ≤ 1.5×ULN * Prior to and during study, and lasting 120 days for the final utilization of pembrolizumab, patients approve of contraception * Patients voluntarily agree to participate in the study and sign the informed consent form Exclusion Criteria: * Prior treatment for OCSCC (sugery, immunotherapy, radiotherapy, chemotherapy) * Patients with metastatic OCSCC with an unknown primary tumor site * Patients with infectious disease: AIDS, hepatitis, active tuberculosis * Received a live vaccine within 30 days prior to the first dose of pembrolizumab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin ( BCG ), typhoid vaccine, or attenuated flu vaccine * 5.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab * Currently receiving any other investigational agents * Has a history of allergic reactions attributed to compounds of similar chemical of biologic composition to pembrolizumab or other agents used in the study * Patients with ongoing or active infectoin requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements * Has a or more active autoimmune disease * Has a history( non-infectious ) pneumonitis that required steroids or current pneumonitis
References
Publications (0)
Data not yet available
No reference posted for this study.