Actively Recruiting
A Bidirectional Observational Clinical Study of Tumor Regression Patterns in Patients With Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy
Led by Zhujiang Hospital · Updated on 2025-08-21
35
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) to understand tumor regression patterns and treatment outcomes. This study collects data both retrospectively and prospectively from patients treated with neoadjuvant immunochemotherapy. The focus is on evaluating treatment safety, effectiveness, and survival rates over several years. Participants receive two cycles of neoadjuvant immunochemotherapy using tislelizumab combined with paclitaxel and cisplatin or carboplatin. This single-arm, single-center study tracks treatment outcomes and tumor responses. The study uses a bidirectional design, collecting past and ongoing patient data to analyze results comprehensively. During the study, researchers monitor tumor response at 8 weeks, assessing the objective response rate and tumor regression patterns. They also follow participants for two years to measure progression-free survival and assess 5-year overall survival rates. Participants undergo regular evaluations to track their health, treatment effects, and disease status throughout the study period.
CONDITIONS
Brief Title
A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with locally advanced oral squamous cell carcinoma or oropharyngeal squamous cell carcinoma (T3-4) according to AJCC criteria
- Age between 18 and 80 years
- No history of other malignant tumors or prior cancer treatments
- Adequate blood function: WBC ≥3.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥90 g/L
- Adequate liver function: total bilirubin ≤ upper limit of normal, AST and ALT ≤ 2.5 times upper limit of normal
- Adequate renal function: urinary white blood cells < 10, red blood cells < 10, cast count < 5 per high-power field, creatinine ≤ upper limit of normal
- Heart, brain, lung, and other vital organs function and general condition sufficient to tolerate neoadjuvant immunochemotherapy and surgery
- Performance status score ≤2
You will not qualify if you...
- Presence of distant metastasis
- Women who are pregnant or breastfeeding
- Unable to cooperate with regular follow-up due to psychological, social, family, or geographical reasons
- Currently receiving investigational treatment in other clinical studies
- Severe uncontrolled infection or medical illness
- Major organ dysfunction such as decompensated heart, lung, kidney, or liver failure that prevents tolerance of treatment
- Conditions affecting surgery or anesthesia, such as severe organ dysfunction
- Long-term use of immunosuppressive drugs after organ transplantation
- History of other malignant tumors before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed to collect data on tumor regression patterns and progression-free survival without receiving additional interventions as part of the study.
Regular visits for follow-up assessments as per clinical care
Trial Site Locations
Total: 1 location
1
Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xiaozhi LV
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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