Status:
RECRUITING
A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC
Lead Sponsor:
Zhujiang Hospital
Conditions:
Oral Squamous Cell Carcinoma (OSCC)
Oropharyngeal Squamous Cell Carcinoma (SCC)
Eligibility:
All Genders
18-80 years
Brief Summary
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 advan...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07133958
Start Date
July 11 2023
End Date
December 31 2027
Last Update
August 21 2025
Active Locations (1)
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1
Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong
Guangzhou, Guangdong, China