Head and Neck Squamous Cell CarcinomasPhase 3NCT05582265
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)
A Phase 3 study testing Tislelizumab（neoadjuvant）, Cisplatin （neoadjuvant） and Nab-paclitaxel （neoadjuvant） in people with Head and Neck Squamous Cell Carcinomas, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
Trial summary
A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinomas
- What is being tested?
- Tislelizumab（neoadjuvant）, Cisplatin （neoadjuvant） and Nab-paclitaxel （neoadjuvant）
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 3 sitesChina
- Study dates
- 28 Oct 2022to Oct 2030
- Phase
- Phase 3
- 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
Who may be able to join
- Have a histologically confirmed diagnosis of HNSCC which is planned for treatment with curative intent including surgical resection: stage III/IVA.
- Greater than or equal to 18 and less than 80 years of age at time of study entry.
- ECOG performance status of 0 or 1. Measurable disease as per RECIST 1.1. Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
- Adequate hepatic and renal function as demonstrated by
- Serum creatinine < 1.5 X ULN or CrCl > 40mL/min (if using the Cockcroft-Gault formula below):
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- Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)） Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85 AST/ALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Adequate bone marrow function as demonstrated by:
- Absolute Neutrophil Count >1,500/µL Platelets > 100 X 103/µL Hemoglobin > 9.0 g/dL Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of study enrollment.
- Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; "women of reproductive potential" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
- Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition, subjects must consent to allow use of their residual post-operative tissue for research purposes.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.
- If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
- Active, known or suspected autoimmune disease. Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger .
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- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
- Has known active Hepatitis B or C. Known history of active TB (bacillus tuberculosis ).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 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
- Recruiting
Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)
Shenzhen, Nanshan
Yang Wang, Master, 13570827767 ext. +86, 1223072238@qq.com
- Recruiting
Zhong shan people's hospital
Zhongshan, Guangdong, 528400
Yumeng Liu, 13715586749 ext. +86, 814252326@qq.com
About this study
Official title: A Phase 3, Prospective，Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Neck Squamous Cell Carcinoma
A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Squamous Cell Carcinomas
- Being tested
- Tislelizumab（neoadjuvant）, Cisplatin （neoadjuvant）, Nab-paclitaxel （neoadjuvant）, Surgical resection, Cisplatin（adjuvant）
- 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.
Tislelizumab（neoadjuvant）Drug
Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Cisplatin （neoadjuvant）Drug
Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Nab-paclitaxel （neoadjuvant）Drug
Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Surgical resectionProcedure or surgery
Standard of care
Cisplatin（adjuvant）Drug
Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Tislelizumab（adjuvant）Drug
Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
RadiationRadiation
Recommended, standard of care
Carboplatin (neoadjuvant）Drug
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Carboplatin (adjuvant）Drug
Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) | Experimental | Neoadjuvant therapy ( 3 cycles ) ： Cycle1（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1; Cisplatin (IV), dose=75 mg/m2, or Carboplatin (IV), AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1.
Cycle2、3（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1.
Following surgical resection, high risk participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Low risk participants receive 200 mg Tislelizumab Q3W plus radiotherapy as adjuvant therapy. Receives: Drug: Tislelizumab（neoadjuvant）; Drug: Cisplatin （neoadjuvant）; Drug: Nab-paclitaxel （neoadjuvant）; Procedure: Surgical resection; Drug: Cisplatin（adjuvant）; Drug: Tislelizumab（adjuvant）; Radiation: Radiation; Drug: Carboplatin (neoadjuvant）; Drug: Carboplatin (adjuvant） |
| Neoadjuvant Tislelizumab + Chemotherapy (Arm B) | Experimental | Neoadjuvant therapy ( 3 cycles ) ： Cycle1、2、3（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1; Cisplatin (IV), dose=75 mg/m2, or Carboplatin (IV), AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1.
Following surgical resection, high risk participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Low risk participants receive 200 mg Tislelizumab Q3W plus radiotherapy as adjuvant therapy. Receives: Drug: Tislelizumab（neoadjuvant）; Drug: Cisplatin （neoadjuvant）; Drug: Nab-paclitaxel （neoadjuvant）; Procedure: Surgical resection; Drug: Cisplatin（adjuvant）; Drug: Tislelizumab（adjuvant）; Radiation: Radiation; Drug: Carboplatin (neoadjuvant）; Drug: Carboplatin (adjuvant） |
| Up-front Surgery (Arm C) | Other | Following surgical resection, high risk participants receive chemoradiotherapy as adjuvant therapy. Low risk participants receive radiotherapy as adjuvant therapy. Receives: Procedure: Surgical resection; Drug: Cisplatin（adjuvant）; Radiation: Radiation; Drug: Carboplatin (adjuvant） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
Measured: Up to 3 years
Secondary outcomes (5)
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events
High-grade adverse events were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 5.0 criteria.
Measured: From time of first dose of study treatment until the end of follow-up (up to 5 years)
Pathological complete response (pCR) rate
pCR is defined as the absence of invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Measured: Up to 30 days post-sugery
Major Pathological Response (MPR) rate
MPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Measured: Up to 30 days post-sugery
Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
Measured: Up to 5 years
Objective Response Rate (ORR)
The rate of patients with complete remission (CR) or partial response (PR) evaluated by RECIST 1.1 criteria by site radiology review.
Measured: Up to 30 days post-sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start28 Oct 2022
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 537 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan People's Hospital, Guangdong, China, Shenzhen Sixth People's Hospital
- Responsible party
- Principal investigator, Song Fan, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Song Fan, Doctor, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582265
- Sponsor's protocol ID
- SYSKY-2022-256-1
- Status last verified
- May 2024
- First submitted
- 11 Oct 2022
- Last updated
- 17 May 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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective，Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05582265
- Acronym / sponsor ID
- SYSKY-2022-256-1
- Conditions
- Head and Neck Squamous Cell Carcinomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 537 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Zhongshan People's Hospital, Guangdong, China, Shenzhen Sixth People's Hospital
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 17 Oct 2022 (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, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) | Experimental | Drug: Tislelizumab（neoadjuvant）, Drug: Cisplatin （neoadjuvant）, Drug: Nab-paclitaxel （neoadjuvant）, Procedure: Surgical resection, Drug: Cisplatin（adjuvant）, Drug: Tislelizumab（adjuvant）, Radiation: Radiation, Drug: Carboplatin (neoadjuvant）, Drug: Carboplatin (adjuvant）Neoadjuvant therapy ( 3 cycles ) ： Cycle1（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1; Cisplatin (IV), dose=75 mg/m2, or Carboplatin (IV), AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1. Cycle2、3（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1. Following surgical resection, high risk participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Low risk participants receive 200 mg Tislelizumab Q3W plus radiotherapy as adjuvant therapy. |
| Neoadjuvant Tislelizumab + Chemotherapy (Arm B) | Experimental | Drug: Tislelizumab（neoadjuvant）, Drug: Cisplatin （neoadjuvant）, Drug: Nab-paclitaxel （neoadjuvant）, Procedure: Surgical resection, Drug: Cisplatin（adjuvant）, Drug: Tislelizumab（adjuvant）, Radiation: Radiation, Drug: Carboplatin (neoadjuvant）, Drug: Carboplatin (adjuvant）Neoadjuvant therapy ( 3 cycles ) ： Cycle1、2、3（Cycle length: 21 days）：Tislelizumab (IV), dose= 200mg, day=1; Cisplatin (IV), dose=75 mg/m2, or Carboplatin (IV), AUC=5, day=1; Nab-paclitaxel (IV), dose=260mg/m2, day=1. Following surgical resection, high risk participants receive 200 mg Tislelizumab Q3W plus chemoradiotherapy as adjuvant therapy. Low risk participants receive 200 mg Tislelizumab Q3W plus radiotherapy as adjuvant therapy. |
| Up-front Surgery (Arm C) | Other | Procedure: Surgical resection, Drug: Cisplatin（adjuvant）, Radiation: Radiation, Drug: Carboplatin (adjuvant）Following surgical resection, high risk participants receive chemoradiotherapy as adjuvant therapy. Low risk participants receive radiotherapy as adjuvant therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a histologically confirmed diagnosis of HNSCC which is planned for treatment with curative intent including surgical resection: stage III/IVA.
- Greater than or equal to 18 and less than 80 years of age at time of study entry.
- ECOG performance status of 0 or 1. Measurable disease as per RECIST 1.1. Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines.
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
- Adequate hepatic and renal function as demonstrated by
Key exclusion criteria (14 listed)
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0.
- If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
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 |
|---|---|---|
| Tislelizumab（neoadjuvant）Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) |
| Cisplatin （neoadjuvant）Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) |
| Nab-paclitaxel （neoadjuvant）Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) |
| Surgical resectionStandard of care | Procedure or surgery | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A), Up-front Surgery (Arm C) |
| Cisplatin（adjuvant）Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A), Up-front Surgery (Arm C) |
| Tislelizumab（adjuvant）Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) |
| RadiationRecommended, standard of care | Radiation | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A), Up-front Surgery (Arm C) |
| Carboplatin (neoadjuvant）Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A) |
| Carboplatin (adjuvant）Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle | Drug | Neoadjuvant Tislelizumab + Chemotherapy (Arm B), Neoadjuvant Tislelizumab + Reduction of Cycles of Chemotherapy (Arm A), Up-front Surgery (Arm C) |
Primary outcome
Event-free Survival (EFS)
Time frame: Up to 3 years
EFS is the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.
5 secondary outcomes
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events
Time frame: From time of first dose of study treatment until the end of follow-up (up to 5 years)
Pathological complete response (pCR) rate
Time frame: Up to 30 days post-sugery
Major Pathological Response (MPR) rate
Time frame: Up to 30 days post-sugery
Event-free Survival (EFS)
Time frame: Up to 5 years
Objective Response Rate (ORR)
Time frame: Up to 30 days post-sugery
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 17 May 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.
Song Fan, Doctor study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab（neoadjuvant）, Cisplatin （neoadjuvant） and Nab-paclitaxel （neoadjuvant） in people with Head and Neck Squamous Cell Carcinomas, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites 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 14 inclusion and 14 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Song Fan, Doctor (13570536658 ext. +86, fansong2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (EFS) (time frame: Up to 3 years). 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 17 May 2024.