Head and Neck Squamous Cell CarcinomasPhase 2NCT06235918
Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab, Nab-paclitaxel and Carboplatin in people with Head and Neck Squamous Cell Carcinomas and Resectable Head and Neck Squamous-cell Carcinoma, run by Xiang Lu at 1 site in China.
Trial summary
For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinomas, Resectable Head and Neck Squamous-cell Carcinoma
- What is being tested?
- Tislelizumab, Nab-paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily participate in the project and sign the informed consent.
- Be 18 years of age on day of signing informed consent.
- The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1.
- According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma.
- Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.
- Demonstrate adequate organ function.
Who cannot join
- The patient has abnormal blood indicators, abnormal liver and kidney function.
- The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment.
- The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years.
- The entire clinical research process cannot be completed due to personal, social and economic reasons.
- Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Xiang Lu, professor, 027-83662691, luxiangent@hotmail.com
About this study
Official title: Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial
For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .
- Being tested
- Tislelizumab, Nab-paclitaxel, Carboplatin
- 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.
TislelizumabDrug
Also called BGB-A317
Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
Nab-paclitaxelDrug
260mg/m^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
CarboplatinDrug
AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy of tislelizumab with chemotherapy | Experimental | Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles Receives: Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (PCR)
Measured: From neoadjuvant therapy to surgical resection, up to 6 weeks
Secondary outcomes (3)
Major Pathological Response (MPR)
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Measured: From neoadjuvant therapy to surgical resection, up to 6 weeks
3-year Disease-free survival (DFS) rate
Time from randomization to disease recurrence or death of any cause
Measured: 3-years after surgery
3-year overall survival（OS）rate
The proportion of all study cases in which no death from any cause occurred within 3 years after surgery
Measured: 3-years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 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 CarcinomasStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Lu, Tongji Hospital
- Investigators
- Guangyuan Hu, professor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235918
- Sponsor's protocol ID
- TJ-IRB20220529
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT06235918
- Acronym / sponsor ID
- TJ-IRB20220529
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiang LuUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 1 Feb 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.
For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy of tislelizumab with chemotherapy | Experimental | Drug: Tislelizumab, Drug: Nab-paclitaxel, Drug: CarboplatinNeoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who voluntarily participate in the project and sign the informed consent.
- Be 18 years of age on day of signing informed consent.
- The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1.
- According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma.
- Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.
Key exclusion criteria (5 listed)
- The patient has abnormal blood indicators, abnormal liver and kidney function.
- The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment.
- The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years.
- The entire clinical research process cannot be completed due to personal, social and economic reasons.
- Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .
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 |
|---|---|---|
| TislelizumabAlso: BGB-A317Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles | Drug | Neoadjuvant therapy of tislelizumab with chemotherapy |
| Nab-paclitaxel260mg/m^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles | Drug | Neoadjuvant therapy of tislelizumab with chemotherapy |
| CarboplatinAUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles | Drug | Neoadjuvant therapy of tislelizumab with chemotherapy |
Primary outcome
Pathological Complete Response (PCR)
Time frame: From neoadjuvant therapy to surgical resection, up to 6 weeks
3 secondary outcomes
Major Pathological Response (MPR)
Time frame: From neoadjuvant therapy to surgical resection, up to 6 weeks
3-year Disease-free survival (DFS) rate
Time frame: 3-years after surgery
3-year overall survival（OS）rate
Time frame: 3-years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Guangyuan Hu, professor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Nab-paclitaxel and Carboplatin in people with Head and Neck Squamous Cell Carcinomas and Resectable Head and Neck Squamous-cell Carcinoma, run by Xiang Lu 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 6 inclusion and 5 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 1 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xiang Lu, professor (027-83662691, luxiangent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (PCR) (time frame: From neoadjuvant therapy to surgical resection, up to 6 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 1 Feb 2024.