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

Launched by ZHUJIANG HOSPITAL · Aug 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with advanced oral or throat cancers (specifically oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma). The treatment combines immunotherapy (which helps the body’s immune system fight cancer) with chemotherapy before surgery, to see how well it works in shrinking tumors and improving survival over time. Researchers will also look at how safe the treatment is and how the cancer responds to it.

Adults between 18 and 80 years old with locally advanced tumors in the mouth or throat, who have not had other cancers or cancer treatments before, might be eligible for this study. Participants need to be generally healthy enough to handle the treatment and surgery, with good blood, liver, and kidney function. If accepted, patients will receive two cycles of the combined immunotherapy and chemotherapy at the hospital, followed by surgery and regular follow-up visits. The study aims to understand treatment effects over the next few years, including how long patients live without the cancer returning and overall survival. Women who are pregnant or breastfeeding, those with distant cancer spread, or with serious health problems may not qualify.

Gender

ALL

Eligibility criteria

• 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