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Oral Squamous Cell CarcinomaPhase 2NCT06009861

Neoadjuvant Tislelizumab Plus Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer (NeoSPOT)

A Phase 2 study testing Tislelizumab, Albumin-Bound Paclitaxel and Cisplatin in people with Oral Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by Peking University Hospital of Stomatology at 13 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Previous studies confirmed locally advanced oral/oropharyngeal squamous cell carcinoma (LA OSCC or OPSCC) patients with a pathological response had higher probability of survival in neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck cancer showed promising results. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tislelizumab, Albumin-Bound Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
13 sitesChina
Study dates
27 Jun 2023to 30 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cytological or histological diagnosis of initially or potentially surgically resectable Local advanced oral/oropharyngeal squamous cell carcinoma (stage III-IV).
  • Plan to proceed neoadjuvant therapy.
  • No prior anti-cancer treatment (include surgery, radiotherapy and systemic therapy) for oral/oropharyngeal squamous cell carcinoma.
  • Clinically evaluable lesions per RECIST1.1.
  • The age of signing the informed consent is 18-80 years old, regardless of gender.
  • ECOG performance score 0-1.
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  • Estimated survival time≥6 months (this criterion overlaps with other inclusion criteria and must meet the following: ECOG score 0-1; Vital organ function meets the inclusion criteria in Article 8; Oral or oropharyngeal cancer does not involve the internal carotid artery; No subcutaneous metastases; No distant metastasis).
  • Adequate organ function as follows: 1) Leukocyte count ≥ 3,000/mm3; 2) Absolute neutrophil count ≥ 1,500/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum creatinine ≤ 1.5 × ULN OR CrCl≥50 ml/min（Cockcroft-Gault）; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) < 2.5 × ULN;
  • Subjects able and willing to follow research and follow-up procedures.
  • For male and female subjects of childbearing age must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment.
  • Subjects voluntarily joined the clinical study and signed the informed consent.

Who cannot join

  • Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.
  • History of allergy, and may have a potential allergy or intolerance to the investigational drug and its similar biologics.
  • Participated in clinical trials of other antitumor drugs within 4 weeks prior to initial administration; Or receive live attenuated vaccine within 4 weeks prior to initial administration or during the study period;
  • Subjects with concurrent other active malignancies. History of other types for cancer within past 5 years (exclude adequately treated skin squamous cell carcinoma or controlled skin basal cell carcinoma).
  • Advanced subjects with symptoms, visceral dissemination, and a short-term risk of life-threatening complications (including uncontrolled massive exudation [pleural, pericardial, peritoneal], pulmonary lymphangitis, and more than 30% liver involvement).
  • Subjects with active autoimmune disease or history of refractory autoimmune disease.
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  • Subjects with grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥450 ms in men and ≥470 ms in women), NYHA class III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% on echocardiography, myocardial infarction within 6 months before enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggestive of acute ischemia or active conduction system abnormalities;
  • Severe infection (e.g. requiring intravenous antibiotics, antifungal or antiviral medication) within 4 weeks before first dose, or unexplained fever >38.5°C during screening/before first dose;
  • Subjects with a history of abuse of psychotropic substances and unable to withdraw from them or with mental disorders;
  • Subjects undergone major surgery or have an open wound or fracture within 4 weeks before the first dose;
  • 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 above the lower limit of detection of the analytical method) or co-infection of hepatitis B and hepatitis C;
  • Central nervous system metastasis;
  • Subjects with a history of genetic or acquired bleeding or coagulation dysfunction (eligibility criteria at the investigator's discretion);
  • Other conditions that the investigator determined were inappropriate for participation in the study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Peking University School and Hospital Stomatology

    Beijing, Beijing Municipality, 100000

  • The Hospital of Stomatology of Jilin University

    Changchun, Jilin

  • Affiliated Hospital of Chifeng College

    Chifeng, Inner Mongolia

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Shandong Provincial Hospital

    Jinan, Shandong

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • China Medical University School and Hospital Of Stomatology

    Shenyang, Liaoning

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Shanxi Cancer hospital

    Taiyuan, Shanxi

  • Tangshan People's Hospital

    Tangshan, Hebei

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: Neoadjuvant Chemoimmunotherapy With Tislelizumab, Albumin-bound Paclitaxel, and Cisplatin in Locally Advanced Oral/Oropharyngeal Squamous Cell Carcinoma: A Prospective, Multicenter, Single-arm Study

Previous studies confirmed locally advanced oral/oropharyngeal squamous cell carcinoma (LA OSCC or OPSCC) patients with a pathological response had higher probability of survival in neoadjuvant settings. Several ongoing trials of neoadjuvant immunotherapy in head and neck cancer showed promising results. However, the optimal regimen remains unclear. This trial aimed to evaluate the efficacy and safety of neoadjuvant therapy with anti-programmed cell death 1 monoclonal antibody Tislelizumab and chemotherapy, followed by surgery and adjuvant radiotherapy or chemoradiotherapy plus Tislelizumab in LA OSCC or OPSCC.

Being tested
Tislelizumab, Albumin-Bound Paclitaxel, Cisplatin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • TislelizumabDrug

    Dose: 200 mg Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks

  • Albumin-Bound PaclitaxelDrug

    Dose: 260 mg/m^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks

  • CisplatinDrug

    Dose: 60-75 mg/m^2 Route: Intravenous infusion Frequency \& treatment mode: Day 1, every 3 weeks

Study groups in NCT06009861
Study groupRoleWhat they receive
Neoadjuvant Tislelizumab plus chemotherapy and adjuvant RT or Tislelizumab plus CCRTExperimentalNeoadjuvant phase: Patients will receive neoadjuvant Tislelizumab in combination with Albumin-Bound Paclitaxel and Cisplatin Q3W for 2 cycles. Adjuvant phase: For High-risk group(non-R0 resection or extranodal extension (ENE) or Lymph node metastasis>5): Concurrent chemoradiotherapy followed by Tislelizumab Q3W for 14 cycles. For the other group: intensity-modulated radiation therapy.
Receives: Drug: Tislelizumab; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin

What is being measured

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

  1. Rate of Event free survival (EFS) at 2 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.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Major Pathological Response (mPR)

    The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. 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-surgery

  2. Pathological Complete Response (pCR)

    Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.

    Measured: Up to 30 days post-surgery

  3. Overall response rate (ORR)

    Overall response rate (ORR) is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

    Measured: UP to 30 days prior-surgery

  4. Overall survival (OS)

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

    Measured: Up to 2 years

  5. Adverse events (AEs)

    Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions per NCI-CTCAE V5.0.

    Measured: Up to 2 years

Timeline

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

  1. First posted24 Aug 2023
  2. Study start27 Jun 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06009861
Sponsor's protocol ID
PKUSSIRB-202386047
Status last verified
Jun 2025
First submitted
16 Aug 2023
Last updated
6 Jun 2025
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, Albumin-Bound Paclitaxel and Cisplatin in people with Oral Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by Peking University Hospital of Stomatology at 13 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 11 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Event free survival (EFS) at 2 years (time frame: Up to 2 years). 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 NCT06009861.

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 6 Jun 2025.

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