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Tirellizumab Combined With TP Neoadjuvant Therapy in the Treatment of Early Oral Squamous Cell Carcinoma （HNC-SYSU-005）

NCT07267286 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-05

No results posted yet for this study

Summary

Efficacy of Tirellizumab combined with TP neoadjuvant in the treatment of early Oral squamous cell carcinoma (cT1-2N0M0) versus standard treatment: a randomized controlled, single-center exploratory clinical study. Surgery is usually the preferred treatment for early oral squamous cell carcinoma (OSCC). However, the five-year survival rate of early oral cancer is only 75.8%, which is still not satisfactory compared with breast cancer and lung cancer. It is an urgent problem to explore the treatment mode of early oral squamous cell carcinoma patients. This study intends to conduct neoadjuvant therapy of tirellizumab, carboplatin and albumin-bound paclitaxel (TP) in patients with cT1-2N0M0 oral squamous cell carcinoma after neoadjuvant immunotherapy and standard surgical treatment (radical resection of oral cancer + selective neck lymph dissection). A randomized controlled, single-center exploratory clinical study compared with traditional radical resection of oral cancer plus selective neck lymph dissection was conducted to investigate its effectiveness through the difference of 2-year event-free survival (EFS).

This study plans to include 60 patients with early oral squamous cell carcinoma. The subjects will press 1: The proportion of 1 was randomly divided into Tirellizumab combined with TP neoadjuvant therapy combined with surgery (experimental group) and traditional surgery (control group). Tumor tissues, adjacent tissues, whole blood samples, saliva samples and stool samples of patients were collected to observe the imaging and pathological changes before and after treatment. Meanwhile, clinical information of patients was collected. Such as postoperative function and other quality of life indicators, pathological grade, stage, treatment, prognosis, serology, imaging, etc., the main evaluation and comparison of the experimental group and the control group of 2-year event-free survival (EFS) and 5-year overall survival (OS).

Conditions

  • HNSCC
  • PD-1

Interventions

DRUG

Tirellizumab combined with carboplatin and albumin-paclitaxel neoadjuvant therapy+surgery

Tirellizumab 200mg will be administered on day 1 of each 21-day cycle (once every 3 weeks). Tirelizumab will be administered by intravenous infusion using an intravenous catheter containing a sterile, pyrogen free, low protein-binding, 0.2 or 0.22 micron diameter embedded filter or auxiliary filter. As a routine precaution, patients must be monitored for at least 60 minutes in an area equipped with resuscitation equipment and first aid medication after the infusion of tirellizumab during cycle 1 and day 1 of cycle 2. Starting with cycle 3, it is required to be monitored for more than 30 minutes (inclusive) in an area equipped with resuscitation equipment and first aid medication. The first infusion (day 1 of Cycle 1) will be completed within 60 minutes; If it is well tolerated, subsequent infusions can be completed within 30 minutes, which is the minimum time allowed by the infusion. Tirellizumab should not be administered at the same time as any other drug.The surgical method was exte

PROCEDURE

Traditional surgery

The control group was treated according to NCCN guidelines, including radical resection of oral cancer combined with selective neck lymphatic dissection

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2028-08-31
Completion
2032-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267286 on ClinicalTrials.gov