Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130332
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-11-01
Brief Title:
Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell CarcinomaHNC-SYSU-004
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Single-center Exploratory Clinical Study of Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma cT1-2N0M0
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None