Condition: Locally Advanced Oral Squamous Cell Carcinoma · Oral Squamous Cell Carcinoma (OSCC) · Sponsor: Qunxing Li,MD
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, pathol…
This description comes directly from the study's public registry record.
Liansheng Wang, PhD (Candidate) · +8613535330603 · wanglsh25@mail2.sysu.edu.cn
Qunxing Li, MD, PhD · 86+18320699771 · liqx73@mail.sysu.edu.cn
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07371611