OncoMatch/Clinical Trials/NCT07371611
Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma
Is NCT07371611 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Sintilimab plus nab-paclitaxel and platinum-based chemotherapy for locally advanced oral squamous cell carcinoma.
Treatment: Sintilimab plus nab-paclitaxel and platinum-based chemotherapy — This is a multicenter, open-label, randomized phase III clinical trial evaluating perioperative treatment with sintilimab combined with chemotherapy in patients with locally advanced oral squamous cell carcinoma. Despite standard treatment with surgery followed by postoperative radiotherapy or chemoradiotherapy, patients with locally advanced oral squamous cell carcinoma remain at high risk of recurrence or metastasis. Recent evidence, including results from the KEYNOTE-689 study, suggests that perioperative immunotherapy may improve survival outcomes, and this approach has been incorporated into NCCN guidelines. Combining immunotherapy with chemotherapy may further improve prognosis in this patient population. Eligible participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive neoadjuvant sintilimab combined with chemotherapy followed by surgery and postoperative treatment based on pathological response. Patients with major pathological response (MPR) will receive adjuvant sintilimab, while patients without MPR will receive postoperative radiotherapy or concurrent chemoradiotherapy combined with sintilimab. The control group will receive standard treatment consisting of surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated. The primary objective of the study is to compare event-free survival between the two groups. Secondary objectives include overall survival, pathological response, safety, and treatment-related adverse events. The results of this study may help optimize perioperative treatment strategies and improve outcomes for patients with locally advanced oral squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1/PD-L1/PD-L2 or CTLA-4 inhibitor
Prior treatment targeting PD-1, PD-L1, PD-L2, or CTLA-4, or other therapies targeting T-cell costimulatory or immune checkpoint pathways.
Cannot have received: systemic antitumor therapy
Exception: patients who have had ≥12 months of treatment-free interval between the last chemotherapy and initiation of neoadjuvant therapy
Prior systemic antitumor therapy, except patients who have had ≥12 months of treatment-free interval between the last chemotherapy and initiation of neoadjuvant therapy.
Cannot have received: radiotherapy
History of radiotherapy involving the head, neck, or maxillofacial regions.
Cannot have received: allogeneic organ or hematopoietic stem cell transplantation
Exception: excluding corneal transplantation
Previous allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplantation).
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L without G-CSF within 14 days prior to testing. Platelet count ≥ 100 × 10⁹/L without blood transfusion within previous 14 days. Hemoglobin >90 g/L without blood transfusion or erythropoietin use within previous 14 days.
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min. Renal dysfunction: urine protein ≥++ on urinalysis and 24-hour urinary protein >1.0 g [excluded].
Liver function
Total bilirubin ≤ 1.5 × ULN; ≤ 3 × ULN in cases of Gilbert's syndrome or non-hepatic indirect bilirubin elevation. ALT and AST ≤ 2.5 × ULN; ≤ 5 × ULN for patients with hepatic involvement.
Cardiac function
Normal myocardial enzyme profile (minor laboratory abnormalities deemed clinically insignificant by investigator are acceptable). Severe arrhythmias, unstable angina, congestive heart failure (NYHA class ≥ II) [excluded].
Adequate major organ function, meeting all of the following laboratory criteria: ... Normal myocardial enzyme profile ... Severe or uncontrolled systemic diseases, including but not limited to: Cardiac disorders: severe arrhythmias, unstable angina, congestive heart failure (NYHA class ≥ II) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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