Oral Squamous Cell Carcinoma (OSCC)NCT07133958
A Bidirectional Observational Clinical Study of NAIC in the Treatment of Tumor Regression Patterns in LA-OSCC and LA-OPSCC
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (SCC), run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (SCC)
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Stomatology, Zhujiang Hospital, Southern Medical University,Guangzhou, Guangdong
Guangzhou, Guangdong
Xiaozhi Lv, +86-020-62782092, lxzsurgeon@126.com
About this study
Official 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
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.
Read the detailed description
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.
- Keywords
- Oral squamous cell carcinoma, Oropharyngeal squamous cell carcinoma, neoadjuvant immunochemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
two-year progression-free survival rate
The proportion of patients who remain alive and progression-free for 2 years aftertreatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start11 Jul 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133958
- Sponsor's protocol ID
- 2024-KY-195
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07133958
- Acronym / sponsor ID
- 2024-KY-195
- Keywords
- Oral squamous cell carcinoma, Oropharyngeal squamous cell carcinoma, neoadjuvant immunochemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Tumor regression pattern
Time frame: 8 weeks
two-year progression-free survival rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (SCC), run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaozhi LV (+86-020-62782092, lxzsurgeon@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0bjective Response Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.