Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07371611

Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma

Led by Qunxing Li,MD · Updated on 2026-01-28

104

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years at the time of enrollment.
  • ECOG Performance Status (PS) score of 0-1.
  • Primary lesion pathologically confirmed as oral squamous cell carcinoma (OSCC), including tumors of the anterior two-thirds of the tongue, gingiva, buccal mucosa, floor of the mouth, hard palate, or retromolar trigone.
  • Clinical stage III or IVA, defined as T1-2 with N1-2, or T3-4a and/or N0-2, according to the AJCC 8th edition OSCC TNM staging system.
  • Willingness to undergo surgical treatment.
  • Presence of at least one measurable lesion as defined by RECIST v1.1 criteria.
  • Voluntary participation with full understanding and signing of the informed consent form, and willingness to comply with study procedures.
  • Adequate major organ function, meeting all of the following laboratory criteria:
    1. Absolute neutrophil count (ANC) 21 1.5 d 109/L without granulocyte colony-stimulating factor (G-CSF) administration within 14 days prior to testing.
    1. Platelet count 21 100 d 109/L without blood transfusion within the previous 14 days.
    1. Hemoglobin > 90 g/L without blood transfusion or erythropoietin use within the previous 14 days.
    1. Total bilirubin 24 1.5 d the upper limit of normal (ULN); 24 3 d ULN in cases of Gilbert's syndrome or non-hepatic indirect bilirubin elevation.
    1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 24 2.5 d ULN; 24 5 d ULN for patients with hepatic involvement.
    1. Serum creatinine 24 1.5 d ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) 21 60 mL/min.
    1. Adequate coagulation function, defined as INR or prothrombin time (PT) 24 1.5 d ULN.
    1. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with abnormal TSH may be enrolled if total T3 (or FT3) and FT4 are within normal limits.
    1. Normal myocardial enzyme profile (minor laboratory abnormalities deemed clinically insignificant by the investigator are acceptable).
    1. For women of childbearing potential, a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment (Cycle 1, Day 1) is required. If the urine test is indeterminate, a serum test must be performed. Non-childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy.
    1. All participants (male or female) with reproductive potential must agree to use highly effective contraception (annual failure rate <1%) during the entire treatment period and for at least 120 days after the last study drug dose or 180 days after the last chemotherapy dose.
Not Eligible

You will not qualify if you...

  • Prior treatment targeting PD-1, PD-L1, PD-L2, or CTLA-4, or other therapies targeting T-cell costimulatory or immune checkpoint pathways.
  • Participation in another interventional clinical trial or use of an investigational drug or device within 4 weeks prior to the first dose.
  • History of radiotherapy involving the head, neck, or maxillofacial regions.
  • Use of traditional Chinese medicines or immunomodulatory agents with OSCC indications within 2 weeks before first dosing; local therapy for pleural effusion control is permitted.
  • History of active autoimmune disease within the past 2 years requiring systemic therapy (exceptions: controlled hypothyroidism, diabetes mellitus, adrenal or pituitary insufficiency).
  • Use of systemic corticosteroid therapy within 1 week prior to the first dose is prohibited; other immunosuppressive drugs are prohibited. Intranasal, inhaled, or topical corticosteroids and physiologic doses of corticosteroids (e.g., prednisone 2410 mg/day) are permitted.
  • Prior systemic antitumor therapy except if treatment-free interval of at least 12 months before neoadjuvant therapy.
  • Previous allogeneic organ or hematopoietic stem cell transplantation (excluding corneal transplantation).
  • Known hypersensitivity to sintilimab, carboplatin, cisplatin, nab-paclitaxel, or their excipients.
  • Failure to recover to baseline or 241 (except fatigue or alopecia) from adverse events or complications of prior interventions.
  • Known HIV infection (HIV-1/2 antibody positive).
  • Untreated active hepatitis B infection (with some exceptions if controlled and monitored).
  • Active hepatitis C infection.
  • Receipt of a live vaccine within 30 days prior to first dose (inactivated vaccines allowed).
  • Pregnant or breastfeeding women.
  • Severe or uncontrolled systemic diseases including cardiac, vascular, pulmonary, infectious, gastrointestinal, hepatic, diabetes, renal, psychiatric disorders.
  • Any other condition deemed unsuitable by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510123

Actively Recruiting

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Research Team

L

Liansheng Wang, PhD (Candidate)

CONTACT

Q

Qunxing Li, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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