A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhujiang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
8 weeksSecondary outcomes
1
Tumor regression pattern
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.
Time frame
8 weeks2
two-year progression-free survival rate
The proportion of patients who remain alive and progression-free for 2 years aftertreatment
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov