NCT07133958

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jul 2023Dec 2027

Study Start

First participant enrolled

July 11, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

3.7 years

First QC Date

August 14, 2025

Last Update Submit

August 14, 2025

Conditions

Oral Squamous Cell Carcinoma (OSCC)Oropharyngeal Squamous Cell Carcinoma (SCC)

Keywords

Oral squamous cell carcinomaOropharyngeal squamous cell carcinomaneoadjuvant immunochemotherapy

Outcome Measures

Primary Outcomes (1)

  • 0bjective Response Rate

    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.

    8 weeks

Secondary Outcomes (2)

  • Tumor regression pattern

    8 weeks

  • two-year progression-free survival rate

    2 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants were planned to receive 2 cycles of intravenous neoadjuvant Tislelizumab (200 mg) every 3 weeks,and Paclitaxel 135-175mg/m2, Cisplatin 80-120mg/m2 or Carboplatin 0.3-0.4g/m2 through intravenous infusion each 3-week cycle for 2cycles.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Central Study Contacts

Xiaozhi LV

CONTACT

+86-020-62782092lxzsurgeon@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 21, 2025

Study Start

July 11, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations

CN(1)