Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer.
Ravindra Uppaluri, Robert I Haddad, Yungan Tao...
https://pubmed.ncbi.nlm.nih.gov/40532178Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID07371611
Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma: A Multicenter, Open-label, Randomized Phase III Clinical Study
Led by Qunxing Li,MD · Updated on 2026-01-28
104
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating perioperative treatment with sintilimab combined with chemotherapy in patients who have locally advanced oral squamous cell carcinoma, a common head and neck cancer. This phase III, multicenter, randomized clinical trial aims to improve survival outcomes, as patients remain at high risk of recurrence or metastasis despite standard surgery and postoperative radiotherapy or chemoradiotherapy. Recent studies suggest that adding immunotherapy during the perioperative period may enhance patient prognosis and has been recommended in clinical guidelines. Participants will be randomly assigned to one of two groups. The experimental group receives neoadjuvant sintilimab combined with chemotherapy before surgery, followed by postoperative treatment based on their pathological response. Patients showing a major pathological response (MPR) will continue with adjuvant sintilimab, while those without MPR will receive postoperative radiotherapy or chemoradiotherapy combined with sintilimab. The control group will undergo standard treatment with surgery followed by postoperative radiotherapy or chemoradiotherapy as needed. Throughout the study, participants will be closely monitored with radiologic assessments at baseline and before surgery. Researchers will evaluate event-free survival as the primary outcome over two years, along with secondary outcomes including overall survival, pathological response, and treatment-related side effects. Safety and adverse events will be tracked for about one year. The study expects to provide important information to optimize treatment strategies and improve outcomes for patients with this type of oral cancer.
CONDITIONS
Brief 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
You may qualify if you...
- Aged 18 to 75 years at the time of enrollment.
- ECOG Performance Status score of 0 or 1.
- Primary lesion pathologically confirmed as oral squamous cell carcinoma (OSCC) in specified oral regions.
- Clinical stage III or IVA as defined by AJCC 8th edition OSCC TNM staging.
- Willingness to undergo surgical treatment.
- At least one measurable lesion according to RECIST v1.1.
- Voluntary participation with informed consent and compliance willingness.
- Adequate major organ function meeting specified blood counts and laboratory criteria.
- Negative pregnancy test for women of childbearing potential before first dose.
- Agreement to use highly effective contraception during treatment and specified periods after last dose.
You will not qualify if you...
- Prior treatment targeting PD-1, PD-L1, PD-L2, CTLA-4, or other immune checkpoint pathways.
- Participation in another interventional trial or use of investigational drugs/devices within 4 weeks prior.
- History of radiotherapy to head, neck, or maxillofacial regions.
- Use of certain traditional Chinese medicines or immunomodulatory agents within 2 weeks before dosing.
- Active autoimmune disease requiring systemic therapy within past 2 years, with some exceptions.
- Use of systemic corticosteroids or other immunosuppressive drugs near study start.
- Prior systemic antitumor therapy without at least 12 months treatment-free interval.
- Previous allogeneic organ or stem cell transplantation (excluding corneal).
- Known hypersensitivity to study drugs or their components.
- Incomplete recovery from prior treatment side effects.
- Known HIV infection.
- Untreated active hepatitis B or C infection with specific criteria.
- Receipt of live vaccine within 30 days before first dose.
- Pregnant or breastfeeding women.
- Severe or uncontrolled systemic diseases including cardiac, vascular, pulmonary, infectious, gastrointestinal, hepatic, metabolic, renal, psychiatric disorders.
- Any condition making participation unsuitable as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Run-in Period
Duration - Duration of neoadjuvant treatment period prior to surgery
Participants in the experimental arm receive neoadjuvant sintilimab combined with chemotherapy prior to surgery.
Visits corresponding to neoadjuvant treatment administration and monitoring
Surgery
Duration - Single day for surgery with immediate post-operative care
Participants undergo radical surgical resection of oral squamous cell carcinoma.
1 visit (in-person) for surgery and immediate post-operative care
Adjuvant Treatment
Duration - At least six cycles or until unacceptable toxicity
Postoperative treatment is stratified by pathological response: participants with major pathological response receive adjuvant sintilimab for at least six cycles or until unacceptable toxicity; participants without major pathological response receive postoperative radiotherapy or concurrent chemoradiotherapy followed by sequential sintilimab.
Regular visits for adjuvant therapy administration and monitoring
Postoperative Radiotherapy or Chemoradiotherapy
Duration - Duration of postoperative radiotherapy or chemoradiotherapy as per standard clinical practice
Participants in the control arm undergo radical surgery followed by postoperative radiotherapy or concurrent chemoradiotherapy as clinically indicated.
Visits for radiotherapy or chemoradiotherapy sessions according to clinical schedule
Follow-up
Duration - Up to 5 years
Participants are monitored for event-free survival, overall survival, safety, and treatment-related adverse events after completion of treatment.
Periodic follow-up visits for up to 5 years
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)
Q
Qunxing Li, MD, PhD
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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