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Neoadjuvant Sintilimab Plus Chemotherapy for cT2N0M0 Oral Squamous Cell Carcinoma

Sponsor: caohaotian

Summary

This study is a superiority multi-center, open-label, phase III randomized controlled trial. It will further verify the clinical value of xidili single-antibody combined with chemotherapy (albumin paclitaxel and carboplatin) in neoadjuvant treatment for operable cT2N0M0 early oral squamous cell carcinoma (Oral Squamous Cell Carcinoma, OSCC) patients in terms of improving long-term survival and pathological remission. The study subjects are patients aged 18-75 years, diagnosed with cT2N0M0 stage (8th edition AJCC staging as stage II) OSCC by pathology, with ECOG score of 0-1, good organ function, and meeting laboratory standards (ANC ≥ 1.5 × 10⁹/L, Hb \> 90g/L, CrCl ≥ 60ml/min, ALT/AST ≤ 2.5 × ULN); Exclusion criteria include previous immunotherapy with immune checkpoint inhibitors, active autoimmune diseases, poorly controlled comorbidities, high viral load infection of HBV/HCV, etc.; Patients with surgical resection conditions and signing informed consent will be enrolled. The subjects were randomly divided into two groups at a ratio of 1:1: The experimental group received neoadjuvant treatment with xidili single-antibody combined with albumin paclitaxel and carboplatin for 2-3 cycles followed by surgery (primary lesion resection + I-III region cervical lymph node dissection), while the control group received standard treatment (direct surgery). The primary endpoint of the study is the 3-year event-free survival rate (Event-Free Survival rate, EFS rate), and secondary endpoints include overall survival rate (Overall survival rate, OS rate), major pathological response rate (Major Pathological Response, MPR), complete pathological response rate (Complete Pathological Response, pCR), objective response rate (Objective Response Rate, ORR), safety analysis (Treatment-Related Adverse Event, TRAE), and postoperative lymph node positive rate (Lymph Node Positivity rate, LNP rate). The sample size was calculated based on the Log-rank test, referring to the prospective clinical baseline data of standard surgical treatment for early oral cancer, setting the 3-year EFS rate of the control group at 80%, assuming that the experimental group can be improved to 90% (HR = 0.47), setting a two-sided α = 0.05, efficacy 80%, and follow-up dropout rate 10%, a total of 300 patients (150 in each group) need to be enrolled. This study will provide high-quality evidence-based evidence for optimizing the treatment strategy for cT2N0M0 early high-risk oral squamous cell carcinoma, improving the pathological response rate and long-term recurrence-free survival.

Official title: Sintilimab Combined With Chemotherapy as Neoadjuvant Therapy for cT2N0M0 Early-Stage Oral Squamous Cell Carcinoma: A Multicenter, Randomized Controlled, Open-Label, Superiority, Phase III Clinical Trial

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