Head and Neck Cancer Squamous Cell CarcinomaPhase 2NCT07457346
A Study Testing Emactinib Sulfate With Chemotherapy and Immunotherapy Before Surgery for Advanced Head and Neck Cancer
A Phase 2 study testing cisplatin+ nab-paclitaxel +adebrelimab + imaxitinib in people with Head and Neck Cancer Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of a novel combination therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). The therapy combines the JAK1 inhibitor Sulfamethoxazole, the anti-PD-L1 antibody Adebrelimab, and chemotherapy (Nab-paclitaxel + Cisplatin) as a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer Squamous Cell Carcinoma
- What is being tested?
- cisplatin+ nab-paclitaxel +adebrelimab + imaxitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Aug 2030
- 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
- ECOG Performance Status of 0-1.
- Histologically and/or cytologically confirmed Stage III-IVA head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx).
- Classified according to the Asia-Pacific multidisciplinary consensus (Y.Guo et al., Oral Oncol 2024):
- Cohort A: Resectable** (amenable to upfront surgery): T2N2-3M0, T3-4N0-2M0 (AJCC 8th edition).
- Cohort B: Potentially Resectable:** Cases with relative contraindications to surgery (e.g., cervical lesion directly invading skin, anterior 2/3 tongue tumor extending below the hyoid level, extension to the vallecula) or where surgery would cause significant disfigurement/functional loss, requiring discussion by an MDT (head \& neck surgery, radiology) to weigh risks vs. non-surgical options.
- Cohort C: Unresectable: Tumor extensively invading skull base, extending to nasopharynx/deep nasopharyngeal wall, invading/encasing carotid artery, extending to mediastinal structures, prevertebral fascia, or cervical spine; T3-4 (N0-3) or any N2a-3 (T1-4) M0 (AJCC 8th edition).
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- Biomarker: Peripheral blood flow cytometry analysis showing that PD-1+TIM-3+CD8+ exhausted T cells account for >10% of CD8+ T cells.
- Adequate baseline organ function within 14 days prior to enrollment:
- Hematological: White Blood Cell count (WBC) ≥4000/μL, Absolute Neutrophil Count (ANC) ≥2000/μL, Hemoglobin (HGB) ≥9 g/dL, Platelet count (PLT) ≥100,000/μL.
- Renal: Serum creatinine <1.5 times the Upper Limit of Normal (ULN) OR Creatinine Clearance (CrCl) >60 mL/min (calculated by Cockcroft-Gault formula).
- Hepatic: Total bilirubin ≤1.5x ULN (except subjects with Gilbert's syndrome, who may have total bilirubin <3x ULN); Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤3x ULN; Alkaline Phosphatase (ALP) ≤3x ULN; Albumin (ALB) ≥3 g/dL.
- Ability to understand and willingness to sign the Informed Consent Form. Subjects must be willing and able to comply with the protocol, including receiving treatments and scheduled visits/examinations, including follow-up.
Who cannot join
- Prior treatment with immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agents) or JAK inhibitors. History of severe allergic reactions to any component of monoclonal antibodies.
- Active autoimmune disease or condition requiring immunosuppressive therapy. Subjects requiring systemic corticosteroids or other immunosuppressive drugs prior to enrollment.
- History of other active malignancies or active infections (including tuberculosis and hepatitis); uncontrolled infections (HIV, HBV, HCV).
- Severe cardiac or pulmonary dysfunction, including severe cardiac insufficiency (e.g., NYHA Class III or higher) or severe pulmonary dysfunction (e.g., FEV1 <50% predicted); history of thrombotic diseases, coagulation disorders (Prothrombin Time (PT) >16 seconds, Activated Partial Thromboplastin Time (APTT) >53 seconds, Thrombin Time (TT) >21 seconds, Fibrinogen (FIB) <1.5 g/L), bleeding tendency, or current thrombolytic/anticoagulant therapy.
- Pregnant or lactating women. Subjects unwilling to use effective contraception during the study period.
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
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Ting Zhang phD, +86571-87783521, zezht@zju.edu.cn
phD
About this study
Official title: A Pilot Trial of Neoadjuvant Sulfate Emactinib Plus Chemo-immunotherapy for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck.
The goal of this clinical trial is to evaluate the efficacy and safety of a novel combination therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). The therapy combines the JAK1 inhibitor Sulfamethoxazole, the anti-PD-L1 antibody Adebrelimab, and chemotherapy (Nab-paclitaxel + Cisplatin) as a neoadjuvant treatment (given before surgery). The main questions it aims to answer are:
- For patients with resectable locally advanced HNSCC: Can this combination improve the pathological complete response (pCR) rate (the absence of viable cancer cells in the surgical specimen) compared to current neoadjuvant therapies?
- For patients with potentially resectable or unresectable locally advanced HNSCC: Can this combination improve the objective response rate (ORR) (the percentage of patients with significant tumor shrinkage), potentially making surgery possible or reducing its scope?
Read more
Researchers will also assess secondary outcomes including event-free survival (EFS), overall survival (OS), and the safety profile of the combination.
Participants will:
- Receive neoadjuvant treatment with the combination of Sulfamethoxazole, Adebrelimab, and chemotherapy. A key feature is the timed sequencing of the JAK inhibitor, which will be started on day 8 of each treatment cycle.
- Be evaluated for surgery after the neoadjuvant treatment. For those who undergo surgery, the pathological response will be analyzed.
- Have regular follow-up assessments, including imaging studies (such as CT or MRI scans) and safety monitoring, to evaluate long-term treatment response, survival, and side effects.
- Provide tissue and/or blood samples for exploratory biomarker analysis (e.g., Interferon-Stimulated Gene signature) to help identify patients who benefit most from this treatment.
Read the detailed description
Head and Neck Squamous Cell Carcinoma (HNSCC) represents a significant and growing health burden in China, with approximately 60% of new patients diagnosed at locally advanced (Stage III/IV) disease. Despite the application of multidisciplinary team (MDT) approaches, the prognosis for these patients remains poor, characterized by a 2-year recurrence rate of 50%-60%, a 20%-30% rate of distant metastasis, and a 5-year overall survival (OS) rate below 50%. Standard-of-care for locally advanced HNSCC involves surgery ± radiotherapy/chemoradiotherapy for resectable cases and platinum-based concurrent chemoradiotherapy (CRT) for unresectable cases. However, significant unmet therapeutic needs persist.
The advent of immune checkpoint inhibitors (ICIs), such as PD-1/PD-L1 antibodies, has revolutionized treatment for recurrent/metastatic HNSCC, prompting exploration in the neoadjuvant setting. Previous studies suggest that neoadjuvant immunotherapy combined with chemotherapy can improve pathological complete response (pCR) rates in resectable locally advanced HNSCC, potentially increasing operability or reducing the extent of surgery to better preserve organ function. Adebrelimab is a novel, domestically developed humanized anti-PD-L1 monoclonal antibody. It blocks the PD-1/PD-L1 pathway to reactivate anti-tumor immunity and is designed for high specificity towards PD-L1, potentially leading to a favorable safety profile. Its efficacy and safety, combined with chemotherapy, have been demonstrated in cancers like extensive-stage small cell lung cancer and esophagogastric junction adenocarcinoma.
Recent groundbreaking research published in Science (June 2024) highlights a promising strategy to overcome ICI resistance by combining ICIs with JAK inhibitors. This combination can increase anti-tumor T and NK cell numbers and reverse T-cell exhaustion. Crucially, JAK inhibitors can prevent T-cell exhaustion induced by Type I Interferon (IFN-I) signaling. When combined with ICIs, they restore T-cell function, leading to enhanced anti-tumor efficacy. A key finding is that a temporally sequenced administration strategy-delaying the initiation of the JAK inhibitor-can preserve beneficial early immune activation while counteracting resistance mechanisms, as validated in preclinical models. Furthermore, an Interferon-Stimulated Gene (ISG) signature (e.g., IFIT1/MX1) may serve as a predictive biomarker to identify patients with active interferon signaling who are more likely to benefit from this approach.
Based on this compelling rationale, this clinical trial aims to investigate the combination of a JAK1 inhibitor with neoadjuvant chemoimmunotherapy in locally advanced HNSCC. A critical feature of the trial design is the implementation of the temporally sequenced dosing strategy for the JAK inhibitor, initiating it from day 8 of each treatment cycle to optimize the immune response and mitigate resistance.
In summary, this study seeks to address the critical unmet needs in locally advanced HNSCC by evaluating a novel, mechanistically rational combination of a JAK1 inhibitor (sulfamethoxazole) with neoadjuvant chemoimmunotherapy (adebrelimab + nab-paclitaxel/cisplatin), utilizing an innovative timed-sequencing approach. The trial aims to demonstrate improved efficacy and manageable safety, while pioneering biomarker-driven strategies for patient selection in this challenging disease.
- Being tested
- cisplatin+ nab-paclitaxel +adebrelimab + imaxitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin+ nab-paclitaxel +adebrelimab + imaxitinibDrug
Treatment is administered in 21-day cycles, with a response assessment after 2 cycles. On Day 1 of each cycle, patients receive cisplatin (60mg/m²) plus nab-paclitaxel (260mg/m²) concurrently with adebrelimab (1200mg). Starting from Day 8 through Day 21 of each cycle, patients orally take 4mg of imaxitinib daily.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment (chemotherapy+immunotherapy+JAKi) | Experimental | Patients are stratified into three cohorts based on resectability status:
Cohort A (Resectable) + Cohort B (Potentially Resectable) + Cohort C (Unresectable) All enrolled patients receive the same neoadjuvant therapy. Receives: Drug: cisplatin+ nab-paclitaxel +adebrelimab + imaxitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate in Cohort A (Resectable)
The proportion of participants in Cohort A (resectable locally advanced HNSCC) who achieve a pathological complete response (pCR) upon histopathological examination of the surgical resection specimen after 2 cycles of neoadjuvant therapy. pCR is defined as the absence of viable tumor cells (ypT0 ypN0) as per College of American Pathologists (CAP) criteria.
Measured: approximately 12-14 weeks from the start of treatment
Objective Response Rate (ORR) in Cohort B (Potentially Resectable)
The proportion of participants in Cohort B (potentially resectable locally advanced HNSCC) who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, assessed via imaging (CT/MRI) after 2 cycles of neoadjuvant therapy.
Measured: approximately 6 weeks from the start of treatment
Objective Response Rate (ORR) in Cohort C (Unresectable)
The proportion of participants in Cohort C (unresectable locally advanced HNSCC) who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, assessed via imaging (CT/MRI) after 2 cycles of neoadjuvant therapy.
Measured: approximately 6 weeks from the start of treatment
Secondary outcomes (3)
Event-Free Survival (EFS)
EFS is defined as the time from enrollment to the occurrence of any of the following events: disease progression that precludes planned curative surgery (for Cohorts A/B), local or regional recurrence after definitive therapy (surgery or radiotherapy), distant metastasis, or death from any cause.
Measured: assessed up to 3 years.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: assessed up to 3 years.
Incidence of Treatment-Related Adverse Events (TRAEs)
The frequency and severity of all adverse events assessed as related to the study intervention (Adebrelimab, Sulfamethoxazole, cisplatin, and nab-paclitaxel). Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This includes the incidence of serious adverse events (SAEs), adverse events leading to treatment discontinuation or dose reduction, and specific events of interest such as immune-related adverse events (irAEs) and hematological toxicities.
Measured: From the first dose of study treatment until 90 days after the last dose. Continuous monitoring throughout the study, expected to be approximately 6 months for the neoadjuvant and definitive therapy phases, plus the 90-day safety follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jan 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 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 Cancer Squamous Cell CarcinomaStudies 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
- Model description
- Patients are stratified into three cohorts based on resectability status: Cohort A (Resectable)+Cohort B (Potentially Resectable)+ Cohort C (Unresectable). All enrolled patients receive the same neoadjuvant therapy.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457346
- Sponsor's protocol ID
- Y2025-0723
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Neoadjuvant Sulfate Emactinib Plus Chemo-immunotherapy for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck.
- ClinicalTrials.gov ID
- NCT07457346
- Acronym / sponsor ID
- Y2025-0723
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 9 Mar 2026 (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 clinical trial is to evaluate the efficacy and safety of a novel combination therapy for locally advanced head and neck squamous cell carcinoma (HNSCC). The therapy combines the JAK1 inhibitor Sulfamethoxazole, the anti-PD-L1 antibody Adebrelimab, and chemotherapy (Nab-paclitaxel + Cisplatin) as a neoadjuvant treatment (given before surgery). The main questions it aims to answer are:
- For patients with resectable locally advanced HNSCC: Can this combination improve the pathological complete response (pCR) rate (the absence of viable cancer cells in the surgical specimen) compared to current neoadjuvant therapies?
- For patients with potentially resectable or unresectable locally advanced HNSCC: Can this combination improve the objective response rate (ORR) (the percentage of patients with significant tumor shrinkage), potentially making surgery possible or reducing its scope?
Researchers will also assess secondary outcomes including event-free survival (EFS), overall survival (OS), and the safety profile of the combination.
Participants will:
- Receive neoadjuvant treatment with the combination of Sulfamethoxazole, Adebrelimab, and chemotherapy. A key feature is the timed sequencing of the JAK inhibitor, which will be started on day 8 of each treatment cycle.
- Be evaluated for surgery after the neoadjuvant treatment. For those who undergo surgery, the pathological response will be analyzed.
- Have regular follow-up assessments, including imaging studies (such as CT or MRI scans) and safety monitoring, to evaluate long-term treatment response, survival, and side effects.
- Provide tissue and/or blood samples for exploratory biomarker analysis (e.g., Interferon-Stimulated Gene signature) to help identify patients who benefit most from this treatment.
Detailed description
Head and Neck Squamous Cell Carcinoma (HNSCC) represents a significant and growing health burden in China, with approximately 60% of new patients diagnosed at locally advanced (Stage III/IV) disease. Despite the application of multidisciplinary team (MDT) approaches, the prognosis for these patients remains poor, characterized by a 2-year recurrence rate of 50%-60%, a 20%-30% rate of distant metastasis, and a 5-year overall survival (OS) rate below 50%. Standard-of-care for locally advanced HNSCC involves surgery ± radiotherapy/chemoradiotherapy for resectable cases and platinum-based concurrent chemoradiotherapy (CRT) for unresectable cases. However, significant unmet therapeutic needs persist.
The advent of immune checkpoint inhibitors (ICIs), such as PD-1/PD-L1 antibodies, has revolutionized treatment for recurrent/metastatic HNSCC, prompting exploration in the neoadjuvant setting. Previous studies suggest that neoadjuvant immunotherapy combined with chemotherapy can improve pathological complete response (pCR) rates in resectable locally advanced HNSCC, potentially increasing operability or reducing the extent of surgery to better preserve organ function. Adebrelimab is a novel, domestically developed humanized anti-PD-L1 monoclonal antibody. It blocks the PD-1/PD-L1 pathway to reactivate anti-tumor immunity and is designed for high specificity towards PD-L1, potentially leading to a favorable safety profile. Its efficacy and safety, combined with chemotherapy, have been demonstrated in cancers like extensive-stage small cell lung cancer and esophagogastric junction adenocarcinoma.
Recent groundbreaking research published in Science (June 2024) highlights a promising strategy to overcome ICI resistance by combining ICIs with JAK inhibitors. This combination can increase anti-tumor T and NK cell numbers and reverse T-cell exhaustion. Crucially, JAK inhibitors can prevent T-cell exhaustion induced by Type I Interferon (IFN-I) signaling. When combined with ICIs, they restore T-cell function, leading to enhanced anti-tumor efficacy. A key finding is that a temporally sequenced administration strategy-delaying the initiation of the JAK inhibitor-can preserve beneficial early immune activation while counteracting resistance mechanisms, as validated in preclinical models. Furthermore, an Interferon-Stimulated Gene (ISG) signature (e.g., IFIT1/MX1) may serve as a predictive biomarker to identify patients with active interferon signaling who are more likely to benefit from this approach.
Based on this compelling rationale, this clinical trial aims to investigate the combination of a JAK1 inhibitor with neoadjuvant chemoimmunotherapy in locally advanced HNSCC. A critical feature of the trial design is the implementation of the temporally sequenced dosing strategy for the JAK inhibitor, initiating it from day 8 of each treatment cycle to optimize the immune response and mitigate resistance.
In summary, this study seeks to address the critical unmet needs in locally advanced HNSCC by evaluating a novel, mechanistically rational combination of a JAK1 inhibitor (sulfamethoxazole) with neoadjuvant chemoimmunotherapy (adebrelimab + nab-paclitaxel/cisplatin), utilizing an innovative timed-sequencing approach. The trial aims to demonstrate improved efficacy and manageable safety, while pioneering biomarker-driven strategies for patient selection in this challenging disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are stratified into three cohorts based on resectability status: Cohort A (Resectable)+Cohort B (Potentially Resectable)+ Cohort C (Unresectable). All enrolled patients receive the same neoadjuvant therapy.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment (chemotherapy+immunotherapy+JAKi) | Experimental | Drug: cisplatin+ nab-paclitaxel +adebrelimab + imaxitinibPatients are stratified into three cohorts based on resectability status: Cohort A (Resectable) + Cohort B (Potentially Resectable) + Cohort C (Unresectable) All enrolled patients receive the same neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ECOG Performance Status of 0-1.
- Histologically and/or cytologically confirmed Stage III-IVA head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx).
- Classified according to the Asia-Pacific multidisciplinary consensus (Y.Guo et al., Oral Oncol 2024):
- Biomarker: Peripheral blood flow cytometry analysis showing that PD-1+TIM-3+CD8+ exhausted T cells account for >10% of CD8+ T cells.
- Adequate baseline organ function within 14 days prior to enrollment:
Key exclusion criteria (5 listed)
- Prior treatment with immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 agents) or JAK inhibitors. History of severe allergic reactions to any component of monoclonal antibodies.
- Active autoimmune disease or condition requiring immunosuppressive therapy. Subjects requiring systemic corticosteroids or other immunosuppressive drugs prior to enrollment.
- History of other active malignancies or active infections (including tuberculosis and hepatitis); uncontrolled infections (HIV, HBV, HCV).
- Severe cardiac or pulmonary dysfunction, including severe cardiac insufficiency (e.g., NYHA Class III or higher) or severe pulmonary dysfunction (e.g., FEV1 <50% predicted); history of thrombotic diseases, coagulation disorders (Prothrombin Time (PT) >16 seconds, Activated Partial Thromboplastin Time (APTT) >53 seconds, Thrombin Time (TT) >21 seconds, Fibrinogen (FIB) <1.5 g/L), bleeding tendency, or current thrombolytic/anticoagulant therapy.
- Pregnant or lactating women. Subjects unwilling to use effective contraception during the study period.
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 |
|---|---|---|
| cisplatin+ nab-paclitaxel +adebrelimab + imaxitinibTreatment is administered in 21-day cycles, with a response assessment after 2 cycles. On Day 1 of each cycle, patients receive cisplatin (60mg/m²) plus nab-paclitaxel (260mg/m²) concurrently with adebrelimab (1200mg). Starting from Day 8 through Day 21 of each cycle, patients orally take 4mg of imaxitinib daily. | Drug | Neoadjuvant treatment (chemotherapy+immunotherapy+JAKi) |
Primary outcome
Pathological Complete Response (pCR) Rate in Cohort A (Resectable)
Time frame: approximately 12-14 weeks from the start of treatment
The proportion of participants in Cohort A (resectable locally advanced HNSCC) who achieve a pathological complete response (pCR) upon histopathological examination of the surgical resection specimen after 2 cycles of neoadjuvant therapy. pCR is defined as the absence of viable tumor cells (ypT0 ypN0) as per College of American Pathologists (CAP) criteria.
Objective Response Rate (ORR) in Cohort B (Potentially Resectable)
Time frame: approximately 6 weeks from the start of treatment
The proportion of participants in Cohort B (potentially resectable locally advanced HNSCC) who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, assessed via imaging (CT/MRI) after 2 cycles of neoadjuvant therapy.
Objective Response Rate (ORR) in Cohort C (Unresectable)
Time frame: approximately 6 weeks from the start of treatment
The proportion of participants in Cohort C (unresectable locally advanced HNSCC) who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, assessed via imaging (CT/MRI) after 2 cycles of neoadjuvant therapy.
3 secondary outcomes
Event-Free Survival (EFS)
Time frame: assessed up to 3 years.
Overall Survival (OS)
Time frame: assessed up to 3 years.
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From the first dose of study treatment until 90 days after the last dose. Continuous monitoring throughout the study, expected to be approximately 6 months for the neoadjuvant and definitive therapy phases, plus the 90-day safety follow-up.
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 9 Mar 2026.
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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?
A Phase 2 study testing cisplatin+ nab-paclitaxel +adebrelimab + imaxitinib in people with Head and Neck Cancer Squamous Cell Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 12 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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 Ting Zhang, phD. (+8657187783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate in Cohort A (Resectable) (time frame: approximately 12-14 weeks from the start of treatment). The study lists 3 primary outcomes in all. 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 9 Mar 2026.