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Head &Amp; Neck Squamous Cell CarcinomaPhase 2NeoTempoNCT07147426

Tislelizumab Combined With Chemotherapy for Different Cycles of Neoadjuvant Therapy for Locally Advanced Resectable Squamous Cell Carcinoma of the Head and Neck (NeoTempo)

A Phase 2 study testing Tislelizumab Combined With Chemotherapy for 4 cycles and Tislelizumab Combined With Chemotherapy for 2 cycles in people with Head &Amp; Neck Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head &Amp; Neck Squamous Cell Carcinoma
What is being tested?
Tislelizumab Combined With Chemotherapy for 4 cycles and Tislelizumab Combined With Chemotherapy for 2 cycles
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Oct 2025to 20 Oct 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or pathological diagnosis of head and neck squamous cell carcinoma;
  • Initially resectable stage III-IVB oral cancer/laryngeal cancer/hypopharyngeal cancer/P16-oropharyngeal cancer, or stage III p16+ oropharyngeal cancer (AJCC 8th), and evaluated by the researcher to achieve R0 resection;
  • Plan to perform neoadjuvant therapy;
  • No previous anti-tumor treatment for HNSCC;
  • There is at least one measurable lesion;
  • Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2;
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  • The expected survival period is ≥3 months
  • The functions of vital organs meet the following requirements (excluding any blood components and cell growth factors used within 7 days) :
  • Normal bone marrow reserve function, white blood cell (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥ 1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (Hb) ≥90 g/L; ii. Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥50 ml/min (Cockcroft-Gault formula); iii. Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is ≤ 2.5 times the upper limit of the normal value (ULN).
  • Be able to and willing to abide by the research and follow-up procedures;
  • Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment.
  • The patient voluntarily joined this clinical study, signed the informed consent form, had good compliance and was able to cooperate with the follow-up.

Who cannot join

  • Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell co-stimulation or checkpoint pathways);
  • There is a clear history of allergies, and there may be potential allergies or intolerances to the research drug and its similar biological agents;
  • Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration; Or within 4 weeks before the first administration or planning to receive a live attenuated vaccine during the study period;
  • Other malignant tumors have occurred within the past five years (except for well-treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin);
  • Immunosuppressive drugs have been used within 14 days prior to the first use of tislelizumab, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/ day of prednisolone or equivalent physiological doses of other corticosteroids).
  • Advanced patients with symptoms, who have spread to internal organs and are at risk of life-threatening complications in the short term (including those with uncontrollable large amounts of exudate [thoracic, pericardial, abdominal], pulmonary lymphangitis and more than 30% liver involvement)
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  • Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma has completely relieved in childhood and do not require any intervention in adulthood can be included; Asthma subjects who require bronchodilators for medical intervention cannot be included.
  • Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the NYHA standard, patients with grade Ⅲ to Ⅳ cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography; Myocardial infarction occurred within 6 months before enrollment, New York Heart Association Class II or above heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or abnormal active conduction system
  • Concurrent severe infection within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during the screening period/before the first administration;
  • Those with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders;
  • Major surgical operations have been performed within 4 weeks prior to the first administration. Or have an open wound or fracture;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C;
  • There is central nervous system metastasis;
  • Those with a history of hereditary or acquired bleeding or coagulation disorders (the specific inclusion is determined by the researcher);
  • Other circumstances where the researcher determines that one is not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tianjin Medical University Cancer Institute and Hospital contact

+862223340123

wxd.1133@163.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000

    Tianjin, Tianjin Municipality

    Xudong Wang, 86+022-23340123-3130, wxd.1133@163.com

    Hongling Wang, 86+022-23340123-3130, wanghongling86@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized Controlled, Phase II Clinical Study on the Neoadjuvant Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma With Tislelizumab Combined With Chemotherapy for Different Cycles (NeoTempo)

This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.

Being tested
Tislelizumab Combined With Chemotherapy for 4 cycles, Tislelizumab Combined With Chemotherapy for 2 cycles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab Combined With Chemotherapy for 4 cyclesDrug

    Tislelizumab: 200mg, day 1, every 3 weeks for 4 cycles Cisplatin: 75mg/m^2, day 1, every 3 weeks for 4 cycles Nab-paclitaxel: 260mg/m^2, day 1, every 3 weeks for 4 cycles

  • Tislelizumab Combined With Chemotherapy for 2 cyclesDrug

    Tislelizumab: 200mg, day 1, every 3 weeks for 2 cycles Cisplatin: 75mg/m^2, day 1, every 3 weeks for 2 cycles Nab-paclitaxel: 260mg/m^2, day 1, every 3 weeks for 2 cycles

Study groups in NCT07147426
Study groupRoleWhat they receive
4 cycles armExperimentalNot described
Receives: Drug: Tislelizumab Combined With Chemotherapy for 4 cycles
2 cycles armActive comparatorNot described
Receives: Drug: Tislelizumab Combined With Chemotherapy for 2 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR)

    Pathological complete response (pCR) is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen.

    Measured: 6 months

Secondary outcomes (9)

  1. Major Pathological Response (mPR)

    The percentage of participants with a major pathological response (mPR) is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen.

    Measured: 6 months

  2. Organ perservation rate

    Organ perservation rate defined as the proportion of patients who successfully preserved their organs and functions through neoadjuvant treatment.

    Measured: 6 months

  3. Operation delay rate

    Operation delay rate defined as any change to scheduled surgery date considered to be at least possibly related to neoadjuvant treatment.

    Measured: 6 months

  4. Objective resopnse rate (ORR)

    ORR defined as the proportion of all subjects who achieved complete response (CR) or partial response (PR) as assessed by RECIST V1.1 after the end of neoadjuvant therapy

    Measured: 6 months

  5. 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: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause.

    Measured: 3 years

  6. Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: 3 years

  7. Percentage of adverse events graded by CTCAE v5.0

    Percentage of adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

    Measured: 3 years

  8. Change From Baseline in Quality of Life Scale (QoL) (EORTC QLQ-C30) items 30

    Change from baseline in the combined score of quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 30

    Measured: 3 years

  9. Change From Baseline in Quality of Life Scale (QoL) EOTRC QLQ -H&N 35

    Change from baseline in the combined score of quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire EOTRC QLQ -H\&N 35

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2025
  2. Study start1 Oct 2025
  3. Primary completion20 Oct 2027 (estimated)
  4. Study completion20 Oct 2029 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07147426
Sponsor's protocol ID
E20250855
Acronym
NeoTempo
Status last verified
Aug 2025
First submitted
20 Aug 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab Combined With Chemotherapy for 4 cycles and Tislelizumab Combined With Chemotherapy for 2 cycles in people with Head &Amp; Neck Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 15 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 22 Jul 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 Tianjin Medical University Cancer Institute and Hospital (+862223340123, wxd.1133@163.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: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07147426.

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 22 Jul 2026.

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