Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07133958

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

Led by Zhujiang Hospital · Updated on 2025-08-21

35

Participants Needed

1

Research Sites

233 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with locally advanced oral or oropharyngeal squamous cell carcinoma (T3-4 stage)
  • Aged between 18 and 80 years
  • No history of other malignant tumors or prior cancer treatment
  • White blood cell count of at least 3.5 x 10^9/L
  • Platelet count of at least 75 x 10^9/L
  • Hemoglobin concentration of at least 90 g/L
  • Total bilirubin level within normal limits
  • Aspartate aminotransferase and alanine aminotransferase levels no more than 2.5 times the upper normal limit
  • Urinary white blood cells less than 10 per high-power field
  • Urinary red blood cells less than 10 per high-power field
  • Urinary cast count less than 5 per high-power field
  • Creatinine level within normal limits
  • Heart, brain, lung, and other vital organs functioning well enough to tolerate neoadjuvant immunochemotherapy and surgery
  • Performance status score of 2 or less
Not Eligible

You will not qualify if you...

  • Presence of distant metastasis
  • Pregnant or lactating women
  • Unable to cooperate with regular follow-up due to psychological, social, family, or geographical reasons
  • Currently receiving investigational treatment in another clinical study
  • Severe uncontrolled infection or medical illness
  • Major organ dysfunction such as decompensated heart, lung, kidney, or liver failure
  • Conditions affecting surgery or anesthesia due to severe organ dysfunction
  • Long-term use of immunosuppressive drugs after organ transplantation
  • History of other malignant tumors before enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

X

Xiaozhi LV

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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