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NCT Number: NCT07133958

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

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.

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Key information

Conditions

Oral Squamous Cell Carcinoma (OSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Squamous Cell Carcinoma (SCC) Squamous Cell Carcinoma of Head and Neck

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Xiaozhi Lv

CONTACT

[email protected]

+86-020-62782092

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 0bjective Response Rate

    Time frame: 8 weeks

    According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. it isdefined as the proportion of patients who achieved Complete Response (CR) or Partial Response(PR).Complete Response (CR) was defined as disappearance of all target lesions. PartialResponse (PR) was defined as >=30% decrease in the sum of the longest diameter of targetlesions.

Secondary outcomes

  1. Tumor regression pattern

    Time frame: 8 weeks

    ①Concentric Shrinkage Mode (CS): Refers to a unified inward contraction of tumor cells toward the lesion center as a cohesive unit, without residual scattered tumor foci at the periphery.

    ②Non-Concentric Shrinkage Mode (NCS): Also termed "Dendritic Shrinkage" or "Nest-like/Marginal Shrinkage", characterized by: Heterogeneous regression of the tumor mass, manifesting as: a) Fragmentation of the primary lesion into discontinuous satellite nodules, OR b) Preservation of the original tumor dimensions with heterogeneously reduced density.

  2. two-year progression-free survival rate

    Time frame: 2 years

    The proportion of patients who remain alive and progression-free for 2 years aftertreatment

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaozhi LV

CONTACT

[email protected]

+86-020-62782092

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

A Bidirectional Observational Clinical Study of Tumor Regression Patterns in Patients With Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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