Clinical Trials Logo
  1. Home
  2. PD-1
  3. NCT06130332

Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)

Oral Cancer Clinical Trial

Official title:
A Single-center Exploratory Clinical Study of Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma (cT1-2N0M0)

Clinical Trial Summary

Surgery is usually the first choice for early-stage oral squamous cell carcinoma (OSCC). However, there is currently a lack of consensus on whether patients with clinically negative cervical lymph nodes (N0) should undergo elective neck dissection (END) at the same time. About 20-30% of cT1-2N0M0 oral cancer patients have occult lymph node metastasis, and existing examination methods cannot accurately predict occult cervical lymph node metastasis. Therefore, most clinical retrospective and prospective studies recommend END for cN0 patients. Previous studies have found that no cancer cells were found in the cervical lymph nodes of 70% of patients after END. This unselective END can cause patients with accessory nerve dysfunction, neck scars, etc., and prolong hospitalization and surgery time. Exploring the treatment model for patients with early-stage oral squamous cell carcinoma is an urgent problem that needs to be solved. This study intends to conduct a study on the neoadjuvant treatment of tislelizumab, carboplatin, and albumin-bound paclitaxel. After neoadjuvant immunotherapy in patients with early-stage oral cancer (T1-2N0M0), the primary tumor is treated with standard surgical treatment. Comparison with A single-center exploratory clinical study of traditional oral cancer radical resection + selective neck lymphadenectomy was conducted to explore its effectiveness through the difference in 2-year disease-free survival (DFS). This research plan covers 40 patients with early-stage oral squamous cell carcinoma. They will be randomly divided into tislelizumab, chemotherapy combined with surgery (experimental group) and traditional surgery (control group) in a 1:1 ratio. The patients' tumors will be collected. Tissues, adjacent cancer tissues, whole blood samples, saliva samples, and matrix samples were used to observe the changes in imaging and pathology compared with treatment. At the same time, the clinical information of the patients was collected, such as quality of life indicators such as judgment function, pathological grading, staging, treatment, Spine, serology, imaging, etc., mainly to evaluate the 2-year event-free survival (EFS) between the experimental group and Weather Forecast, and the 3-year overall survival (OS) and patient quality of life between the experimental group and Weather Forecast.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06130332
Study type Interventional
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact
Status Recruiting
Phase Phase 2
Start date September 1, 2023
Completion date August 31, 2030
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06031337 - Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
Completed NCT00158678 - IMRT Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Stage III-IV HNSCC Phase 3
Completed NCT00933387 - A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma Phase 2
Enrolling by invitation NCT05030597 - Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma N/A
Completed NCT03682562 - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Recruiting NCT03684707 - Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions Phase 4
Recruiting NCT04372914 - Prevention of Oral DNA Damage by Black Raspberries N/A
Active, not recruiting NCT03529422 - Durvalumab With Radiotherapy for Adjuvant Treatment of Intermediate Risk SCCHN Phase 2
Recruiting NCT03686020 - Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
Not yet recruiting NCT06060288 - Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
Withdrawn NCT00951470 - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema N/A
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Completed NCT01418118 - Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery Phase 4
Active, not recruiting NCT00232960 - Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC N/A
Recruiting NCT05429099 - Mandibular Reconstruction Preplanning (ViPMR) Phase 2/Phase 3
Completed NCT04614896 - Use of Ultrasound for Measuring Size of Oral Tongue Cancers N/A
Recruiting NCT03685409 - Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions Phase 3
Completed NCT00402779 - Erlotinib Prevention of Oral Cancer (EPOC) Phase 3
Recruiting NCT05153733 - Improved Implant for Reconstruction Purposes After Mandibular Resection N/A
Recruiting NCT02960724 - uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Phase 2