AzTrials
AzTrials

Head and Neck Cancer Squamous Cell CarcinomaPhase 2NCT07145931

Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base

A Phase 2 study testing Neoadjuvant chemoimmunotherapy and Tislelizumab Nab paclitaxel in people with Head and Neck Cancer Squamous Cell Carcinoma and Skull Base--Cancer, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Neoadjuvant chemoimmunotherapy and Tislelizumab Nab paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
20 Sep 2025to 20 Sep 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years, regardless of gender;
  • Histologically confirmed squamous cell carcinoma (including gingiva, buccal mucosa, palate, oropharynx, maxillary sinus, or maxilla/mandible) with radiological evidence of skull base invasion;
  • Measurable tumor lesions (meeting RECIST v1.1 criteria);
  • Treatment-naïve primary T4b-stage patients (N any, per AJCC 8th Edition, 2017);
  • ECOG PS score: 0-1;
  • Medically fit for surgery and chemotherapy, with no surgical contraindications;
  • Women of childbearing potential (18-49 years) must have a negative pregnancy test within 7 days before treatment. Sexually active men and women must agree to use effective contraception during the trial and for 3 months after treatment cessation;
  • Willing to provide written informed consent and comply with scheduled follow-ups, treatments, lab tests, and other study requirements.

Who cannot join

  • Previous anti-tumor treatments including chemotherapy, radiotherapy, or immunotherapy; Refusal to sign informed consent;
  • Patients who refuse the study treatment protocol; patients unable to complete treatment as planned; or patients unable to comply with regular follow-up due to psychological, social, familial or geographical reasons;
  • Patients with known allergies to any study medications;
  • Patients with poor systemic conditions unfit for treatment: as determined by routine tests (complete blood count, blood biochemistry, ECG, chest X-ray, etc.). Poor systemic conditions include: hemoglobin <60g/L, WBC <3.0×10⁹/L, platelets <80×10⁹/L, or serum creatinine >133μmol/L - such patients may be recommended for conservative treatment;
  • Patients with autoimmune diseases requiring long-term immunosuppressive or corticosteroid therapy;
  • Pregnant or lactating women (pregnancy testing should be considered for sexually active women of childbearing potential);
Show all 9Show fewer
  • Patients with current or previous malignancies (except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma);
  • Participation in other clinical trials within 30 days prior to enrollment;
  • Other conditions that may compromise patient safety or compliance as assessed by investigators, including: severe comorbidities (including psychiatric disorders), significantly abnormal laboratory results, or other high-risk familial/social factors.

Trial locations and contacts

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

Yujie Liang contact

+86 13242879610

liangyj35@mail.sysu.edu.cn

China1 site

  • Hospital of Stomatology, Sun Yat-sen University

    Guangzhou, Guangdong, 510055

    Yujie Liang, +86 13242879610, liangyj35@mail.sysu.edu.cn

    Yahui Wang, +86 13588207217, wangyh526@mail2.sysu.edu.cn

Other trials in China

About this study

Official title: Tislelizumab Combined With Chemotherapy for Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Therapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base: A Prospective, Single-arm, Phase II Clinical Study

This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions:

  • What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma?
  • Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition?
  • Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety.
Read more

Participants will:

  • Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg/m² on Day 1, cisplatin 75mg/m² on Days 1-3) for 3 cycles.
  • Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy.
  • Receive (chemo)radiotherapy 4-6 weeks after surgery.
  • Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.
Being tested
Neoadjuvant chemoimmunotherapy, Tislelizumab Nab paclitaxel
Keywords
Head and Neck Cancer Squamous Cell Carcinoma, Skull Base--Cancer, Neoadjuvant Chemoimmunotherapy, Objective response rate

What participants receive

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

  • Neoadjuvant chemoimmunotherapyProcedure or surgery

    Also called Surgery, Adjuvant immunotherapy

    • Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles.
    • Surgical treatment is performed within 3 weeks after completing neoadjuvant therapy.
    • Postoperative (chemo)radiotherapy is initiated 4-6 weeks after surgery.
    • Following (chemo)radiotherapy, adjuvant immunotherapy (Tislelizumab 200mg) is administered every 3 weeks for a total of 8 cycles.

  • Tislelizumab Nab paclitaxelDrug

    Also called Cisplatin

    Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles.

Study groups in NCT07145931
Study groupRoleWhat they receive
Treatment groupExperimental* Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles. * Surgical treatment is performed within 3 weeks after completing neoadjuvant therapy. * Postoperative (chemo)radiotherapy is initiated 4-6 weeks after surgery. * Following (chemo)radiotherapy, adjuvant immunotherapy (Tislelizumab 200mg) is administered every 3 weeks for a total of 8 cycles.
Receives: Procedure: Neoadjuvant chemoimmunotherapy; Drug: Tislelizumab Nab paclitaxel

What is being measured

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

  1. Objective response rate

    Objective Response Rate (ORR) is a pivotal efficacy endpoint in oncology therapeutic evaluation, defined as the proportion of patients whose tumor burden shrinks to a prespecified threshold (achieving either complete or partial response). This metric is measured using internationally standardized criteria (RECIST 1.1), with radiographic imaging to monitor changes in the sum of target lesion diameters. Based on Standardized Criteria (e.g., RECIST 1.1). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in tumor size (sum of target lesions). ORR = CR + PR (expressed as a percentage).

    Measured: Within 3 weeks after completion of neoadjuvant therapy

Secondary outcomes (8)

  1. Number of participants with Adverse Events

    To evaluate the adverse events during the study period according to the NCI-CTCAE, version 5.0, including vital signs, physical examination, laboratory tests, changes in ECOG score, etc., as well as adverse events and serious adverse events, are calculated to the incidence of adverse events and serious adverse events.

    Measured: Until 21 days after the end of the study

  2. Pathologic Efficacy

    The percentage of residual tumor cells in tumor bed of pathological specimens after surgery. Pathological complete response (pCR) refers to tumors the absence of any viable tumor cells within the tumor bed. Major pathological response (MPR) is defined as 10% or fewer residual viable tumor cells within the tumor bed.

    Measured: Perioperative

  3. Clinical Downstaging Rate

    The proportion of patients with reduction in clinical TNM stage.

    Measured: Within 3 weeks after completion of neoadjuvant therapy.

  4. Surgical Conversion Rate

    The proportion of patients with initially unresectable tumors that become resectable after treatment.

    Measured: Within 3 weeks after completion of neoadjuvant therapy.

  5. R0 Resection Rate

    The proportion of patients achieving complete tumor removal with microscopically negative margins (no residual tumor cells).

    Measured: Perioperative

  6. Organ Preservation Rate

    The proportion of patients who, despite pretreatment tumor invasion into critical organs (e.g., eyeball, internal carotid artery, dura mater), successfully retain the involved organ while still achieving R0 resection.

    Measured: Perioperative

  7. Recurrence-Free Survival

    The time from enrollment until cancer recurrence or death from any cause.

    Measured: Until cancer recurrence or death or the last follow-up, whichever came first, assessed up to 24 months

  8. Overall Survival

    The time from enrollment until death from any cause or the last follow-up.

    Measured: Until death from any cause or the last follow-up, whichever came first, assessed up to 24 months

Timeline

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

  1. First posted28 Aug 2025
  2. Study start20 Sep 2025 (estimated)
  3. Primary completion20 Sep 2027 (estimated)
  4. Study completion20 Sep 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07145931
Sponsor's protocol ID
GHKQ-202503-L011
Status last verified
Aug 2025
First submitted
6 Aug 2025
Last updated
28 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Publications

  • Zhang Z, Wu B, Peng G, Xiao G, Huang J, Ding Q, Yang C, Xiong X, Ma H, Shi L, Yang J, Hong X, Wei J, Qin Y, Wan C, Zhong Y, Zhou Y, Zhao X, Leng Y, Zhang T, Wu G, Yao M, Zhang X, Yang K. Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial. Clin Cancer Res. 2022 Aug 2;28(15):3268-3276. doi: 10.1158/1078-0432.CCR-22-0666.

    PubMed 35766967

  • Patel SA, Gibson MK, Deal A, Sheth S, Heiling H, Johnson SM, Douglas K, Flores M, Blumberg J, Lumley C, Yarbrough WG, Shen C, Chera BS, Bauman JR, Hackman T, Weiss J. A phase 2 study of neoadjuvant chemotherapy plus durvalumab in resectable locally advanced head and neck squamous cell carcinoma. Cancer. 2023 Nov 1;129(21):3381-3389. doi: 10.1002/cncr.34930. Epub 2023 Jul 3.

    PubMed 37395170

  • Wu D, Li Y, Xu P, Fang Q, Cao F, Lin H, Li Y, Su Y, Lu L, Chen L, Li Y, Zhao Z, Hong X, Li G, Tian Y, Sun J, Yan H, Fan Y, Zhang X, Li Z, Liu X. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Commun. 2024 Mar 11;15(1):2177. doi: 10.1038/s41467-024-46444-z.

    PubMed 38467604

  • Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. doi: 10.1200/JCO.2012.43.8820. Epub 2012 Nov 5.

    PubMed 23129742

  • Sharma P, Stecklein SR, Yoder R, Staley JM, Schwensen K, O'Dea A, Nye L, Satelli D, Crane G, Madan R, O'Neil MF, Wagner J, Larson KE, Balanoff C, Kilgore L, Phadnis MA, Godwin AK, Salgado R, Khan QJ, O'Shaughnessy J. Clinical and Biomarker Findings of Neoadjuvant Pembrolizumab and Carboplatin Plus Docetaxel in Triple-Negative Breast Cancer: NeoPACT Phase 2 Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):227-235. doi: 10.1001/jamaoncol.2023.5033.

    PubMed 37991778

  • Romero D. Neoadjuvant chemoimmunotherapy is effective in locally advanced cervical cancer. Nat Rev Clin Oncol. 2024 Feb;21(2):84. doi: 10.1038/s41571-023-00855-x. No abstract available.

    PubMed 38110599

  • Sepesi B, Swisher SG. Role of neoadjuvant chemoimmunotherapy for resectable NSCLC. Nat Rev Clin Oncol. 2022 Aug;19(8):497-498. doi: 10.1038/s41571-022-00647-9. No abstract available.

    PubMed 35585121

  • Masarwy R, Kampel L, Horowitz G, Gutfeld O, Muhanna N. Neoadjuvant PD-1/PD-L1 Inhibitors for Resectable Head and Neck Cancer: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021 Oct 1;147(10):871-878. doi: 10.1001/jamaoto.2021.2191.

    PubMed 34473219

  • Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.

    PubMed 31679945

  • Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ; KEYNOTE-040 investigators. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156-167. doi: 10.1016/S0140-6736(18)31999-8. Epub 2018 Nov 30.

    PubMed 30509740

  • Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.

    PubMed 27718784

  • Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008 May 17;371(9625):1695-709. doi: 10.1016/S0140-6736(08)60728-X.

    PubMed 18486742

  • Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

    PubMed 18784101

  • Ganly I, Patel SG, Singh B, Kraus DH, Bridger PG, Cantu G, Cheesman A, De Sa G, Donald P, Fliss DM, Gullane P, Janecka I, Kamata SE, Kowalski LP, Levine PA, Medina Dos Santos LR, Pradhan S, Schramm V, Snyderman C, Wei WI, Shah JP. Craniofacial resection for malignant paranasal sinus tumors: Report of an International Collaborative Study. Head Neck. 2005 Jul;27(7):575-84. doi: 10.1002/hed.20165.

    PubMed 15825201

  • Head and neck squamous cell carcinoma. Nat Rev Dis Primers. 2020 Nov 26;6(1):93. doi: 10.1038/s41572-020-00233-2. No abstract available.

    PubMed 33243985

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant chemoimmunotherapy and Tislelizumab Nab paclitaxel in people with Head and Neck Cancer Squamous Cell Carcinoma and Skull Base--Cancer, run by Sun Yat-sen 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Aug 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 Yujie Liang (+86 13242879610, liangyj35@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Within 3 weeks after completion of neoadjuvant therapy). 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 NCT07145931, which also lists 15 linked publications.

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 28 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in