Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2OPTimalNCT06470217
Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma
A Phase 2 study testing tirilizumab with albumin-bound paclitaxel and cisplatin and surgery in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- tirilizumab with albumin-bound paclitaxel and cisplatin and surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2024to 19 Jun 2027
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, male or female; Patients with primary stage III-IVa surgically resectable squamous cell carcinoma of the oral cavity with measurable lesions (≥10 mm on spiral CT scan, fulfilling RECIST 1.1 criteria) as confirmed by pathohistology; ECOG score of 0 or 1; Expected survival ≥ 12 weeks; Tumour tissue (paraffin specimen or fresh tumour tissue less than 2 years old) for PD-L1 detection is available; Organ function levels must meet the following requirements (14 days prior to first dose of study drug) Bone Marrow:Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelet (PLT) ≥ 100 x 109/L, Haemoglobin (HB) ≥ 9g/dL (no blood transfusion or receipt of component blood within 14 days prior to the test); Liver: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is hepatic metastasis, AST and ALT are allowed to be ≤ 5 times the upper limit of normal); and Kidney: blood creatinine level less than 1.5 times the upper limit of normal or creatinine clearance ≥60ml/min, urea nitrogen ≤200mg/L; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be enrolled) Urine protein ≤1+, if urine protein >1+, 24-hour urine protein measurement should be collected, and its total amount should be ≤1g; and Normal cardiac function, i.e. normal ECG or abnormalities without clinical significance and left ventricular ejection fraction (LVEF) >50% on cardiac ultrasound.
- Reproductively active female subjects must have a negative serum pregnancy test prior to the first dose of the test drug.
- Reproductively active male or female subjects must be using a highly effective method of contraception (e.g., oral contraceptive pill, intrauterine device, abstinence from sexual intercourse, or barrier method of contraception combined with spermicide) throughout the course of the trial and continue to use contraception for 90 days after completion of treatment; Subjects volunteered to join the study, signed an informed consent form, were compliant and co-operated with follow-up visits.
Who cannot join
- With distant metastatic lesions or localised lesions without indication for surgery (stage IVb or IVc patients); Prior history of a primary tumour of nasopharyngeal carcinoma; Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of study drug; Major surgical procedure performed/received within 4 weeks prior to the first dose of study drug or have not recovered from the side effects of this procedure, live vaccination, immunotherapy, radiotherapy within 2 weeks; Concurrently receiving any other anti-tumour therapy; Patient has any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism; vitiligo that does not require systemic therapy may be included; asthma that has been in complete remission in childhood and does not require any intervention in adulthood may be be included; asthma in which the patient requires medical intervention with bronchodilators cannot be included); Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and continue to do so within 2 weeks prior to enrolment; History of other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, and carcinoma in situ of the cervix; Patients who have received haematopoietic stimulating factors, such as those receiving granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first dose of study drug; Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies or activating or inhibitory drugs targeting T-cell receptors (e.g., OX40, CD137); Positive HIV antibody or syphilis spirochete antibody test results; Patients with active Hepatitis B or Hepatitis C:. If HBsAg or HBcAb is positive, HBV DNA (results above the upper limit of the normal range).
- If HCV antibody test result is positive, add HCV RNA (result above upper limit of normal range); Known hypersensitivity to recombinant humanised PD-1 monoclonal antibody drugs and their components; and Active lung disease (interstitial pneumonitis, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis; Have any uncontrolled clinical problems, including but not limited to. Persistent or active (serious) infections. Medication-uncontrolled hypertension (blood pressure persistently greater than 150/90 mmHg); Poorly controlled diabetes mellitus. Heart disease (class III/IV congestive heart failure or heart block as defined by the New York Heart Association).
- The following within 6 months prior to first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accidents, transient ischaemic attacks, cerebral embolism; Previous stem cell transplant or organ transplant; Persons with a history of psychotropic substance abuse that they are unable to abstain from or persons with a history of psychotic disorders; Other severe, acute, or chronic medical conditions or abnormal laboratory tests that, in the investigator's judgement, may increase the risks associated with participation in the study or may interfere with the interpretation of study results; Patients who, in the judgement of the investigator, have poor compliance, or other conditions that make participation in this trial unsuitable.
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
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Yanan Wang, M.D., 13764278464, wangyan_an@163.com
About this study
Official title: A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel with Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma
The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
Read the detailed description
The dosing regimen in the trial group was: tirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
- Being tested
- tirilizumab with albumin-bound paclitaxel and cisplatin, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirilizumab with albumin-bound paclitaxel and cisplatinDrug
Also called neoadjuvant arm
tirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
surgeryProcedure or surgery
Also called Standard treatment arm
patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment arm | Experimental | tirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. Receives: Drug: tirilizumab with albumin-bound paclitaxel and cisplatin |
| Standard treatment arm | Active comparator | patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year events free survival rate
the percentage of participants documented PD per RECIST 1.1 from enrollment in the neoadjuvant stage, or recurrent or death due to any cause, whichever occurred first.
Measured: up to 36 months
Secondary outcomes (4)
overall survival
OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 36 months
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Measured: 36 months
Quality of life EORTC QLQ-C30 scale
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent)
Measured: 36 months
MPR rate
the percentage of participants viable tumour cells remaining in the tumour bed after neoadjuvant therapy ≤10%, regardless of the presence or absence of viable tumour cells in the lymph nodes
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start19 Jun 2024
- Primary completion19 Jun 2025 (estimated)
- Study completion19 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue He, M.D., Principal investigator, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470217
- Sponsor's protocol ID
- OPTimal-study
- Acronym
- OPTimal
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel with Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06470217
- Acronym / sponsor ID
- OPTimal / OPTimal-study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 19 Jun 2025 (estimated)
- Study completion
- 19 Jun 2027 (estimated)
- First posted
- 24 Jun 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 dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
Detailed description
The dosing regimen in the trial group was: tirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment arm | Experimental | Drug: tirilizumab with albumin-bound paclitaxel and cisplatintirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. |
| Standard treatment arm | Active comparator | Procedure: surgerypatients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years, male or female; Patients with primary stage III-IVa surgically resectable squamous cell carcinoma of the oral cavity with measurable lesions (≥10 mm on spiral CT scan, fulfilling RECIST 1.1 criteria) as confirmed by pathohistology; ECOG score of 0 or 1; Expected survival ≥ 12 weeks; Tumour tissue (paraffin specimen or fresh tumour tissue less than 2 years old) for PD-L1 detection is available; Organ function levels must meet the following requirements (14 days prior to first dose of study drug) Bone Marrow:Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelet (PLT) ≥ 100 x 109/L, Haemoglobin (HB) ≥ 9g/dL (no blood transfusion or receipt of component blood within 14 days prior to the test); Liver: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is hepatic metastasis, AST and ALT are allowed to be ≤ 5 times the upper limit of normal); and Kidney: blood creatinine level less than 1.5 times the upper limit of normal or creatinine clearance ≥60ml/min, urea nitrogen ≤200mg/L; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be enrolled) Urine protein ≤1+, if urine protein >1+, 24-hour urine protein measurement should be collected, and its total amount should be ≤1g; and Normal cardiac function, i.e. normal ECG or abnormalities without clinical significance and left ventricular ejection fraction (LVEF) >50% on cardiac ultrasound.
- Reproductively active female subjects must have a negative serum pregnancy test prior to the first dose of the test drug.
- Reproductively active male or female subjects must be using a highly effective method of contraception (e.g., oral contraceptive pill, intrauterine device, abstinence from sexual intercourse, or barrier method of contraception combined with spermicide) throughout the course of the trial and continue to use contraception for 90 days after completion of treatment; Subjects volunteered to join the study, signed an informed consent form, were compliant and co-operated with follow-up visits.
Key exclusion criteria (3 listed)
- With distant metastatic lesions or localised lesions without indication for surgery (stage IVb or IVc patients); Prior history of a primary tumour of nasopharyngeal carcinoma; Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of study drug; Major surgical procedure performed/received within 4 weeks prior to the first dose of study drug or have not recovered from the side effects of this procedure, live vaccination, immunotherapy, radiotherapy within 2 weeks; Concurrently receiving any other anti-tumour therapy; Patient has any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism; vitiligo that does not require systemic therapy may be included; asthma that has been in complete remission in childhood and does not require any intervention in adulthood may be be included; asthma in which the patient requires medical intervention with bronchodilators cannot be included); Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and continue to do so within 2 weeks prior to enrolment; History of other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, and carcinoma in situ of the cervix; Patients who have received haematopoietic stimulating factors, such as those receiving granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first dose of study drug; Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies or activating or inhibitory drugs targeting T-cell receptors (e.g., OX40, CD137); Positive HIV antibody or syphilis spirochete antibody test results; Patients with active Hepatitis B or Hepatitis C:. If HBsAg or HBcAb is positive, HBV DNA (results above the upper limit of the normal range).
- If HCV antibody test result is positive, add HCV RNA (result above upper limit of normal range); Known hypersensitivity to recombinant humanised PD-1 monoclonal antibody drugs and their components; and Active lung disease (interstitial pneumonitis, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis; Have any uncontrolled clinical problems, including but not limited to. Persistent or active (serious) infections. Medication-uncontrolled hypertension (blood pressure persistently greater than 150/90 mmHg); Poorly controlled diabetes mellitus. Heart disease (class III/IV congestive heart failure or heart block as defined by the New York Heart Association).
- The following within 6 months prior to first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accidents, transient ischaemic attacks, cerebral embolism; Previous stem cell transplant or organ transplant; Persons with a history of psychotropic substance abuse that they are unable to abstain from or persons with a history of psychotic disorders; Other severe, acute, or chronic medical conditions or abnormal laboratory tests that, in the investigator's judgement, may increase the risks associated with participation in the study or may interfere with the interpretation of study results; Patients who, in the judgement of the investigator, have poor compliance, or other conditions that make participation in this trial unsuitable.
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 |
|---|---|---|
| tirilizumab with albumin-bound paclitaxel and cisplatinAlso: neoadjuvant armtirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. | Drug | Neoadjuvant treatment arm |
| surgeryAlso: Standard treatment armpatients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors. | Procedure or surgery | Standard treatment arm |
Primary outcome
2 year events free survival rate
Time frame: up to 36 months
the percentage of participants documented PD per RECIST 1.1 from enrollment in the neoadjuvant stage, or recurrent or death due to any cause, whichever occurred first.
4 secondary outcomes
overall survival
Time frame: 36 months
Number of Participants Experiencing an Adverse Event (AE)
Time frame: 36 months
Quality of life EORTC QLQ-C30 scale
Time frame: 36 months
MPR rate
Time frame: 36 months
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 11 Feb 2025.
- 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.
Yue He, M.D. principal investigator
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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 tirilizumab with albumin-bound paclitaxel and cisplatin and surgery in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 3 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 11 Feb 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.
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?
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 Yanan Wang, M.D. (13764278464, wangyan_an@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year events free survival rate (time frame: up to 36 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 11 Feb 2025.