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Squamous Cell Carcinoma of Head and NeckNCT06125223

PABLIXIMAB as Neoadjuvant Therapy for Head and Neck Squamous-cell Carcinoma

An observational study of Squamous Cell Carcinoma of Head and Neck and Neoadjuvant Therapy, run by Xijing Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
45 participants
Where
No sites listed yet
Study dates
1 Nov 2023to 1 Nov 2026
Phase
Observational
Are there results?
None posted in the registry

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

Study population: A otolaryngology patient at Xijing Hospital.

Who may be able to join

  • age 18-80 years old, including 18 years old and 80 years old;
  • MRI diagnosis of resectable stage III-IVA oropharynx, larynx and hypopharynx squamous-cell carcinoma confirmed by histopathology or cytology;
  • ECOG PS score 0-1;
  • the expression of PD-L1 was detected by immunohistochemistry (TPS and CPS score)
  • having at least one measurable lesion according to RECIST version 1.1;
  • expected survival time ≥6 months;
Show all 11Show fewer
  • The neutrophil count was ≥1.5 × 10^9/L, the platelet count was ≥100 × 10^9/L, the hemoglobin count was ≥90 g/L
  • renal function was normal: serum creatinine ≤1.5×ULN;
  • the liver function was basically normal: serum total bilirubin ≤1.5 × ULN, serum aspartate transaminase (AST)≤2.5×ULN, serum Alanine transaminase (ALT)≤2.5 ×ULN;
  • female patients had to be negative for a urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) ;
  • Sign the written informed consent.

Who cannot join

  • patients were treated with anti-tumor drugs including but not limited to PD-1 inhibitor, CTLA-4 antibody, EGFR monoclonal antibody, EGFR-tki, and anti-angiogenesis drugs;
  • History of autoimmune diseases including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, Rheumatoid Arthritis, inflammatory bowel disease, Antiphospholipid syndrome vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
  • participated in other intervention clinical trials within 30 days before screening;
  • history of other malignancies (except cured skin basal-cell carcinoma) ;
  • the presence of serious and poorly controlled co-morbidities (e.g. heart failure, diabetes, hypertension, liver failure, kidney failure, thyroid disease, mental illness, etc.) ;
  • Known to be infected with HIV or active hepatitis or tuberculosis;
Show all 11Show fewer
  • major surgery or planned surgery within 30 days before the first dose of the trial drug;
  • Persons who are allergic to the use of drugs or their components in the programme;
  • pregnancy (confirmed by blood or urine HCG testing) or lactation in women, or in subjects of reproductive age who were unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
  • it is not suitable for the researcher to participate in this study;
  • Unwilling to participate in the study or unable to sign the informed consent.

About this study

Official title: A Single-arm, Prospective, Phase II Study of PABLIXIMAB Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous-cell Carcinoma

The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma.

The main question it aims to answer is: Pathological complete remission (PCR) rate of tumor after neoadjuvant immunotherapy.

Participants will be asked to perform CT and MRI of head and neck, ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy. And will be following-up for at least 1 year.

Read the detailed description

The secondary questions it aims to answer are:

Objective response rate (ORR) after neoadjuvant therapy

  • R0 resection rate
  • major pathological remission (MPR) rate
  • organ preservation rate
  • event-free survival (EFS)
  • local recurrence-free survival (LRFS)
  • distant metastasis-free survival (DMFS)
  • quality of life score (QoL)
  • overall survival (OS)
  • incidence of adverse events (including neoadjuvant stage AEs and full course AEs) The exploratory question it aims to answer is: clearance of peripheral blood ctDNA.
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What is being measured

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

  1. Pathological complete remission (pCR) rate of tumor after neoadjuvant immunotherapy.

    pCR means that there are no residual living tumor cells in the tumor bed and lymph nodes after neoadjuvant therapy.

    Measured: About 50 days after the start of neoadjuvant immunotherapy.

Secondary outcomes (5)

  1. ORR(objective response rate)

    Objective response rates after neoadjuvant immunotherapy were measured, usually as the proportion of patients whose tumor volume decreased by 30% and maintained over 4 weeks, that is, the sum of the rates of complete response (CR) and partial response (PR) , the higher the ORR, the more patients achieved tumor shrinkage with the treatment.

    Measured: At least 1 year.

  2. R0 resection rate

    R0 resection is the highest standard of tumor resection, which means complete tumor resection with negative margin. The tumor R0 resection rate was calculated for the patients who underwent surgery after the completion of neoadjuvant immunotherapy.

    Measured: At least 1 year.

  3. MPR（major pathological response）

    MPR is defined as the percentage of residual tumor cells in the tumor bed being less than or equal to 10% .

    Measured: At least 1 year.

  4. Overall survival rate

    Overall survival is the proportion of all participants who survived the study period. Overall survival was calculated by dividing the number of people alive by the total number at the start of the study.

    Measured: At least 1 year.

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Researchers should grade the severity of each adverse event. If the severity/intensity of an adverse event is not specified in the guidelines, the investigator can assess it based on the general definition of grade 1-5 and in conjunction with his or her medical judgment.

    Measured: At least 1 year.

Timeline

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

  1. First posted9 Nov 2023
  2. Study start1 Nov 2023 (estimated)
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06125223
Sponsor's protocol ID
KY20232325
Status last verified
Nov 2023
First submitted
31 Oct 2023
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nat Rev Dis Primers. 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3.

    PubMed 33243986

  • Keam B, Machiels JP, Kim HR, Licitra L, Golusinski W, Gregoire V, Lee YG, Belka C, Guo Y, Rajappa SJ, Tahara M, Azrif M, Ang MK, Yang MH, Wang CH, Ng QS, Wan Zamaniah WI, Kiyota N, Babu S, Yang K, Curigliano G, Peters S, Kim TW, Yoshino T, Pentheroudakis G. Pan-Asian adaptation of the EHNS-ESMO-ESTRO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with squamous cell carcinoma of the head and neck. ESMO Open. 2021 Dec;6(6):100309. doi: 10.1016/j.esmoop.2021.100309. Epub 2021 Nov 26.

    PubMed 34844180

  • Caudell JJ, Gillison ML, Maghami E, Spencer S, Pfister DG, Adkins D, Birkeland AC, Brizel DM, Busse PM, Cmelak AJ, Colevas AD, Eisele DW, Galloway T, Geiger JL, Haddad RI, Hicks WL, Hitchcock YJ, Jimeno A, Leizman D, Mell LK, Mittal BB, Pinto HA, Rocco JW, Rodriguez CP, Savvides PS, Schwartz D, Shah JP, Sher D, St John M, Weber RS, Weinstein G, Worden F, Yang Bruce J, Yom SS, Zhen W, Burns JL, Darlow SD. NCCN Guidelines(R) Insights: Head and Neck Cancers, Version 1.2022. J Natl Compr Canc Netw. 2022 Mar;20(3):224-234. doi: 10.6004/jnccn.2022.0016.

    PubMed 35276673

  • Bhatia A, Burtness B. Treating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update. Drugs. 2023 Feb;83(3):217-248. doi: 10.1007/s40265-023-01835-2. Epub 2023 Jan 16.

    PubMed 36645621

  • Veigas F, Mahmoud YD, Merlo J, Rinflerch A, Rabinovich GA, Girotti MR. Immune Checkpoints Pathways in Head and Neck Squamous Cell Carcinoma. Cancers (Basel). 2021 Mar 1;13(5):1018. doi: 10.3390/cancers13051018.

    PubMed 33804419

  • Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, Wolchok JD, Hersey P, Joseph R, Weber JS, Dronca R, Mitchell TC, Patnaik A, Zarour HM, Joshua AM, Zhao Q, Jensen E, Ahsan S, Ibrahim N, Ribas A. Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Ann Oncol. 2019 Apr 1;30(4):582-588. doi: 10.1093/annonc/mdz011.

    PubMed 30715153

  • 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

  • Diaz LA Jr, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fourchardiere C, Rivera F, Elez E, Le DT, Yoshino T, Zhong WY, Fogelman D, Marinello P, Andre T; KEYNOTE-177 Investigators. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022 May;23(5):659-670. doi: 10.1016/S1470-2045(22)00197-8. Epub 2022 Apr 12.

    PubMed 35427471

  • Oliva M, Spreafico A, Taberna M, Alemany L, Coburn B, Mesia R, Siu LL. Immune biomarkers of response to immune-checkpoint inhibitors in head and neck squamous cell carcinoma. Ann Oncol. 2019 Jan 1;30(1):57-67. doi: 10.1093/annonc/mdy507.

    PubMed 30462163

  • Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14.

    PubMed 32665297

  • Ferris RL, Spanos WC, Leidner R, Goncalves A, Martens UM, Kyi C, Sharfman W, Chung CH, Devriese LA, Gauthier H, Chiosea SI, Vujanovic L, Taube JM, Stein JE, Li J, Li B, Chen T, Barrows A, Topalian SL. Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial. J Immunother Cancer. 2021 Jun;9(6):e002568. doi: 10.1136/jitc-2021-002568.

    PubMed 34083421

Questions about this trial

What is this clinical trial studying?

An observational study of Squamous Cell Carcinoma of Head and Neck and Neoadjuvant Therapy, run by Xijing Hospital.

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 11 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

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?

Pathological complete remission (pCR) rate of tumor after neoadjuvant immunotherapy. (time frame: About 50 days after the start of neoadjuvant immunotherapy.). 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 NCT06125223, which also lists 12 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 9 Nov 2023.

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