Head and Neck Squamous Cell CarcinomaNCT06576180
Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Carboplatin（ neoadjuvant）, Paclitaxel （neoadjuvant） and Anti-PD-1 Drugs
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: The patients were diagnosed with head and neck squamous cell carcinoma (stages I-IV) and did not receive treatment. They planned to receive only surgical treatment or combined surgical treatment + chemotherapy and immunotherapy. They were divided into two groups, and the participating groups were selected according to the inclusion criteria.
Who may be able to join
- 1: The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), without treatment, and planned to undergo only surgical treatment or surgical treatment + chemotherapy and immunotherapy.
- 2: Can speak Chinese and have certain reading and writing skills
- 3: Healthy group: Dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors
Who cannot join
- 1: Brain tumor, brain injury, or stroke at baseline or during follow-up
- 2: A history of stroke or a medical condition that puts you at high risk for future dementia or recurrence
- 3: Active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week
- 4: Neurocognitive diseases that affect cognitive function, such as Parkinson's disease or Alzheimer's disease
- 5: History of drug-associated encephalopathy or brain infection
- 6: Patients who change their treatment plan during treatment
- 7: Patients who are currently taking or have taken antidepressants
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, 510000
Song Fan, Doctor, 020-81332477, fansong2@mail.sysu.edu.cn
Song Fan, Doctor
About this study
Official title: Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma: a Prospective Cohort Study
The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Carboplatin（ neoadjuvant）, Paclitaxel （neoadjuvant）, Anti-PD-1 Drugs, Surgical resection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin（ neoadjuvant）Drug
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Paclitaxel （neoadjuvant）Drug
Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Anti-PD-1 DrugsDrug
Anti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Surgical resectionProcedure or surgery
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy+ Surgery group( Group A) | The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy. Receives: Drug: Carboplatin（ neoadjuvant）; Drug: Paclitaxel （neoadjuvant）; Drug: Anti-PD-1 Drugs; Procedure: Surgical resection | |
| Direct surgery group (Group B) | The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery. Receives: Procedure: Surgical resection | |
| Healthy people (Group C) | Healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive adverse events, CoAE
Scores on two or more of the neuropsychological battery tests (NBT) of the HVLT-R, COWA, and TMT are 1.5 SD below the standard mean (or the mean score of an appropriate control group), Or a single test score that is 2.0 SD below the mean can be marked as an objective cognitive adverse event (CoAE).
Measured: Baseline, 9 weeks, 6 months, 12 months
Secondary outcomes (4)
Major pathological response rate
Defined as the proportion of subjects with ≤10% viable tumor cells in resection specimens to total subjects
Measured: Within 30 days after surgery
Montreal Cognitive Assessment, MoCA
Baseline, 9 weeks, 6 months, 12 months
Measured: The total score is obtained by adding up the scores of each item, and the full score is 30 points. The application results of the original English version of the scale designer show that if the number of years of education is ≤12 years, 1 point is added,
perceived cognitive decline events , PCDE
Baseline, 9 weeks, 6 months, 12 months
Measured: 1/2 standard deviation (SD) of the PCI score in the baseline healthy population is defined as a minimal clinically important difference (MCID), and a change in PCI score that exceeds the MCID in each test will be labeled as PCDE.
complete pathological response rate
Defined as the proportion of subjects without viable tumor cells in the resection specimen to the total subjects
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start23 Aug 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Fan, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576180
- Sponsor's protocol ID
- SYSKY-2024-647-01
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06576180
- Acronym / sponsor ID
- SYSKY-2024-647-01
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 23 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Aug 2024 (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.
The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy+ Surgery group( Group A) | – | Drug: Carboplatin（ neoadjuvant）, Drug: Paclitaxel （neoadjuvant）, Drug: Anti-PD-1 Drugs, Procedure: Surgical resectionThe patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgical treatment + combined chemotherapy and immunotherapy. |
| Direct surgery group (Group B) | – | Procedure: Surgical resectionThe patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), untreated, and planned to undergo surgery. |
| Healthy people (Group C) | – | –Healthy people |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were diagnosed with head and neck squamous cell carcinoma (stages I-IV) and did not receive treatment. They planned to receive only surgical treatment or combined surgical treatment + chemotherapy and immunotherapy. They were divided into two groups, and the participating groups were selected according to the inclusion criteria.
Key inclusion criteria (3 listed)
- 1: The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), without treatment, and planned to undergo only surgical treatment or surgical treatment + chemotherapy and immunotherapy.
- 2: Can speak Chinese and have certain reading and writing skills
- 3: Healthy group: Dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors
Key exclusion criteria (7 listed)
- 1: Brain tumor, brain injury, or stroke at baseline or during follow-up
- 2: A history of stroke or a medical condition that puts you at high risk for future dementia or recurrence
- 3: Active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week
- 4: Neurocognitive diseases that affect cognitive function, such as Parkinson's disease or Alzheimer's disease
- 5: History of drug-associated encephalopathy or brain infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboplatin（ neoadjuvant）Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant therapy+ Surgery group( Group A) |
| Paclitaxel （neoadjuvant）Paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant therapy+ Surgery group( Group A) |
| Anti-PD-1 DrugsAnti-PD-1 Drugs 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant therapy+ Surgery group( Group A) |
| Surgical resectionStandard of care | Procedure or surgery | Direct surgery group (Group B), Neoadjuvant therapy+ Surgery group( Group A) |
Primary outcome
cognitive adverse events, CoAE
Time frame: Baseline, 9 weeks, 6 months, 12 months
Scores on two or more of the neuropsychological battery tests (NBT) of the HVLT-R, COWA, and TMT are 1.5 SD below the standard mean (or the mean score of an appropriate control group), Or a single test score that is 2.0 SD below the mean can be marked as an objective cognitive adverse event (CoAE).
4 secondary outcomes
Major pathological response rate
Time frame: Within 30 days after surgery
Montreal Cognitive Assessment, MoCA
Time frame: The total score is obtained by adding up the scores of each item, and the full score is 30 points. The application results of the original English version of the scale designer show that if the number of years of education is ≤12 years, 1 point is added,
perceived cognitive decline events , PCDE
Time frame: 1/2 standard deviation (SD) of the PCI score in the baseline healthy population is defined as a minimal clinically important difference (MCID), and a change in PCI score that exceeds the MCID in each test will be labeled as PCDE.
complete pathological response rate
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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. This study is not recruiting at the moment.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guanzhou, China
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 Head and Neck Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive adverse events, CoAE (time frame: Baseline, 9 weeks, 6 months, 12 months). 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 28 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.