NCT07133958Recruiting
A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC
A Bidirectional Observational Clinical Study of Tumor Regression Patterns in Patients With Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma Treated With Neoadjuvant Immunochemotherapy
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 35 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 11 Jul 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07133958
What you commit to
- Study type: Observational
- Planned participants: 35
- From 11 Jul 2023 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving investigational treatment in addition to other clinical studies (in the treatment phase of a clinical study)
- There are factors affecting surgery or anesthesia, such as severe organ dysfunction
- Long-term use of immunosuppressive agents after organ transplantation
Other illness
- 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
- Patients with a history of other malignant tumors before enrollment
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.