A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC

Zhujiang Hospital

Status: Enrolling

Conditions: Oropharyngeal Squamous Cell Carcinoma (SCC); Oral Squamous Cell Carcinoma (OSCC)

Study type: Observational

Funder types: Other

Identifiers

NCT07133958

2024-KY-195

Details and patient eligibility

About

A prospective collection of 35 cases was conducted at Zhujiang Hospital of Southern Medical University. Patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) from April 2023 onward, who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin/carboplatin) at our institution, were included. The study analyzed treatment safety, efficacy, tumor regression patterns, 2-year progression-free survival (PFS), and 5-year overall survival (OS) rates.

Full description

This study retrospectively collected data from patients in 2023 and prospectively collected data from patients undergoing treatment at the same time. In terms of time type, it is a bidirectional study. Meanwhile, these studies are a single-arm, single-center study and belong to a case series study.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria
2. Their age ranged from 18 to 80 years
3. There was no history of other malignant tumors or treatment
4. Adequate blood function: white blood cell count (WBC) ≥3.5×10^9/L, platelet count (PLT) ≥75×10^9/L; Hemoglobin concentration (HGB) ≥90g/L
5. Adequate liver function: total bilirubin (TBIL) ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal
6. "Adequate renal function: urinary white blood cells < 10, red blood cells < 10, cast count < 5 per high-power field, and creatinine (CRE) ≤ the upper limit of normal.
7. The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment
8. PS score ≤2

Exclusion criteria

1. Presence of distant metastasis
2. Women who are pregnant or lactating
3. Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons
4. Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study)
5. Accompanied by severe uncontrolled infection or medical illness
6. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate NACI or surgical treatment
7. There are factors affecting surgery or anesthesia, such as severe organ dysfunction
8. Long-term use of immunosuppressive agents after organ transplantation
9. Patients with a history of other malignant tumors before enrollment