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

Recruiting now

Conditions studied: Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (SCC)

In brief

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.

Key facts

Study ID

NCT07133958

Run by

Zhujiang Hospital

People needed

35

Starts

2023-07-11

Expected to finish

2027-12-31

Last updated by the study team

2025-08-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma diagnosed as locally advanced (T3-4) according to the AJCC criteria
• Their age ranged from 18 to 80 years
• There was no history of other malignant tumors or treatment
• 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
• 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
• "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.
• The heart, brain, lung and other vital organs function and general condition can tolerate NACI and surgical treatment
• PS score ≤2

You may not qualify if…

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

Where it is running

• Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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