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Squamous Cell Carcinoma of Head and NeckNCT05459415

Reducing Excision Margins After Neoadjuvant Chemoimmunotherapy for HPV Negative Resectable Locally Advanced HNSCC

A study testing Reducing Excision Margins in people with Squamous Cell Carcinoma of Head and Neck and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study aims to explore the 2-year DFS (disease-free survival) rate and organ retention rate and to explore the ORR, PCR rate, 2y-OS， and quality of life of patients. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Reducing Excision Margins
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
22 Jun 2022to 21 Jun 2027
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age is 18-70 years old, gender is unlimited;
  • Histological diagnosis of oral, oropharyngeal, hypopharyngeal, or laryngeal squamous cell carcinoma; preoperative evaluation can be surgical resection.
  • HPV negative evaluation criteria: P16 immunohistochemistry is negative, that is, p16 is less than 70% negative, and negative HPV FISH test shall prevail; locally advanced, defined as per the United States Joint Committee on Cancer [AJCC] guidelines: -HPV negative disease, III, IVa, IVb; no previous tumor treatment for head and neck squamous cell carcinoma;
  • According to the RECIST version 1.1 standard, With at least one evaluable target lesion;
  • the ECOG physical status is 0-1 points;
  • the main organ function is normal, That is, the following standards should meet: (1) routine blood inspection standards should meet: (no blood transfusion within 14 days) a. Hb 90g / L: b. ANC≥1.5x109/L; c. PLT 80x109 / L; (2) biochemical inspection should meet the following standards a.BIL <1.25 times the upper normal value limit (ULN); b.ALT and AST<2.5xULN; In case of liver metastases, Then, ALT and AST <5xULN: c. Serum Cr ULN, Endophytic creatinine clearance> 50ml / min (Cockcroft-Gaut formula);
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  • Signed written informed consent prior to any test-related activity;
  • Investigators judged the ability to comply with the study protocol;
  • pregnancy test at screening (for fertile female patients) negative;
  • Fertility of male patients and female patients at risk of fertility and pregnancy must agree to the use of two contraceptive methods (at least one of which is considered efficient) throughout the study period. Unfertile women (i. e., meet one of at least the following criteria): -hysterectomy and/or bilateral oophorectomy with documented records; -medically confirmed ovarian function decline; -Postmenopausal status, defined as menopause for at least 12 consecutive months of menopause without other pathologic or physiologic reasons and confirmed by serum follicle-stimulating hormone (FSH) levels.
  • Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other research procedures.12 A signed and dated informed consent indicates that the patient (or legal representative, if permitted by local guidelines/practice practices) has been informed of all relevant aspects of the study

Who cannot join

  • Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies (including ipilimumab), or any other antibodies or drugs specifically targeted to the T cell co-stimulation or immune checkpoint pathway.
  • Major surgery for the first 4 weeks before enrollment;
  • People with a proven allergy to PD-1 antibody or its excipients;
  • Any active autoimmune disease or a history of autoimmune disease (e. g., Interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, reduced thyroid function (can be included after effective hormone replacement therapy): vitiligo or asthma in childhood, Asthmatic patients living in adults, either without any intervention and requiring medical intervention with bronchodilators, may be included);
  • Previous or concurrent cases of other malignancies (cured, Except for malignancies with cancer-free survival of more than 5 years, Such as skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma);
  • Heart clinical symptoms or diseases that cannot be controlled, For example: (1) heart failure of grade NYHAII or above (2) unstable heart pattern pain (3) myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
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  • Within 14 days before the administration of the study drug, Subjects who require systemic treatment with corticosteroids (> 10 mg/day, an efficacy dose of prednisone) or other immunosuppressants, In the absence of active autoimmune disease, Allow inhaled or topical use of steroids and adrenal hormone replacement with efficacy doses of prednisone> 10 mg/day；
  • Active infection requiring treatment;
  • Having an innate or acquired immune deficiency (e. g., an HIV-infected person), active hepatitis B (HBV-DNA 104 copy number/ml or 2000IU / ml), or hepatitis C (hepatitis C antibody positive, And HCV-RNA is above the lower limit of analysis);
  • Patients have received other oncology treatments before treatment;
  • Live vaccine within 4 weeks before the start of study treatment;
  • Known history of psychotropic substance abuse, alcohol or drug use;
  • Women during pregnancy or lactation;
  • Researchers judge, Subjects had other factors that could contribute to their forced termination of the study midway, If other serious diseases (including mental illness) require combined treatment, Laboratory examination values were seriously abnormal, Family or social factors, May affect the subject safety or trial data collection;
  • Patients considered not feasible for radical resection;
  • active tuberculosis;
  • Severe infections occurring within 4 weeks prior to initiation of study treatment (including but not limited to hospitalization, due to complications of infection, bacteremia or severe pneumonia);
  • Receiving systemic immune stimulation medication within 4 weeks before initiation of study treatment (including but not limited to interferon or interleukin-2 [IL-2]) or remaining in 5 drug half-lives (older of both).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhanjie Zhang

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Reducing Excision Margins After Neoadjuvant Chemoimmunotherapy for HPV Negative Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (REMATCH)

This study aims to explore the 2-year DFS (disease-free survival) rate and organ retention rate and to explore the ORR, PCR rate, 2y-OS， and quality of life of patients.

Read the detailed description

This study aims to explore the 2-year DFS (disease-free survival) rate and organ retention rate after AP chemotherapy combined with anti-PD-1 antibody neoadjuvant treatment for HPV negative operable locally advanced head and HNSCC, and to explore the ORR, PCR rate, 2y-OS, and quality of life of patients.

Being tested
Reducing Excision Margins
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Margins of Excision

What participants receive

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

  • Reducing Excision MarginsProcedure or surgery

    Reducing Excision Margins After Neoadjuvant Chemoimmunotherapy

Study groups in NCT05459415
Study groupRoleWhat they receive
Reducing Excision MarginsExperimentalIn resectable HPV-negative locally advanced head and neck squamous cell carcinoma, 3 cycles of preoperative neoadjuvant chemotherapy combined with immunotherapy are proposed, in patients with significant tumor shrinkage (≥50%) as assessed by imaging, to conduct research on narrowing the scope of surgery, preserve the patient's organ function, improve or improve the quality of life, and achieve a curative effect that is not inferior to traditional radical surgery
Receives: Procedure: Reducing Excision Margins

What is being measured

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

  1. DFS（disease-free survival）

    2 years disease-free survival

    Measured: 2 years

Secondary outcomes (1)

  1. Organ retention rate

    Organ retention rate

    Measured: 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 posted15 Jul 2022
  2. Study start22 Jun 2022
  3. Primary completion21 Jun 2025 (estimated)
  4. Study completion21 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05459415
Sponsor's protocol ID
REMATCH2201
Status last verified
Jun 2022
First submitted
22 Jun 2022
Last updated
15 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Winquist E, Agbassi C, Meyers BM, Yoo J, Chan KKW; Head and Neck Disease Site Group. Systemic therapy in the curative treatment of head-and-neck squamous cell cancer: Cancer Care Ontario clinical practice guideline. Curr Oncol. 2017 Apr;24(2):e157-e162. doi: 10.3747/co.24.3489. Epub 2017 Apr 27.

    PubMed 28490940

  • Szturz P, Wouters K, Kiyota N, Tahara M, Prabhash K, Noronha V, Castro A, Licitra L, Adelstein D, Vermorken JB. Weekly Low-Dose Versus Three-Weekly High-Dose Cisplatin for Concurrent Chemoradiation in Locoregionally Advanced Non-Nasopharyngeal Head and Neck Cancer: A Systematic Review and Meta-Analysis of Aggregate Data. Oncologist. 2017 Sep;22(9):1056-1066. doi: 10.1634/theoncologist.2017-0015. Epub 2017 May 22.

    PubMed 28533474

  • Lorch JH, Goloubeva O, Haddad RI, Cullen K, Sarlis N, Tishler R, Tan M, Fasciano J, Sammartino DE, Posner MR; TAX 324 Study Group. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):153-9. doi: 10.1016/S1470-2045(10)70279-5. Epub 2011 Jan 11.

    PubMed 21233014

  • Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

    PubMed 17960012

  • 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

  • Pasquali S, Chiarion-Sileni V, Rossi CR, Mocellin S. Immune checkpoint inhibitors and targeted therapies for metastatic melanoma: A network meta-analysis. Cancer Treat Rev. 2017 Mar;54:34-42. doi: 10.1016/j.ctrv.2017.01.006. Epub 2017 Feb 2.

    PubMed 28189914

  • Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.

    PubMed 29658856

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

    PubMed 30280658

  • Duray A, Demoulin S, Hubert P, Delvenne P, Saussez S. Immune suppression in head and neck cancers: a review. Clin Dev Immunol. 2010;2010:701657. doi: 10.1155/2010/701657. Epub 2011 Mar 10.

    PubMed 21437225

  • Ogino T, Shigyo H, Ishii H, Katayama A, Miyokawa N, Harabuchi Y, Ferrone S. HLA class I antigen down-regulation in primary laryngeal squamous cell carcinoma lesions as a poor prognostic marker. Cancer Res. 2006 Sep 15;66(18):9281-9. doi: 10.1158/0008-5472.CAN-06-0488.

    PubMed 16982773

  • 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

  • Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

    PubMed 29658848

  • Cloughesy TF, Mochizuki AY, Orpilla JR, Hugo W, Lee AH, Davidson TB, Wang AC, Ellingson BM, Rytlewski JA, Sanders CM, Kawaguchi ES, Du L, Li G, Yong WH, Gaffey SC, Cohen AL, Mellinghoff IK, Lee EQ, Reardon DA, O'Brien BJ, Butowski NA, Nghiemphu PL, Clarke JL, Arrillaga-Romany IC, Colman H, Kaley TJ, de Groot JF, Liau LM, Wen PY, Prins RM. Neoadjuvant anti-PD-1 immunotherapy promotes a survival benefit with intratumoral and systemic immune responses in recurrent glioblastoma. Nat Med. 2019 Mar;25(3):477-486. doi: 10.1038/s41591-018-0337-7. Epub 2019 Feb 11.

    PubMed 30742122

  • Pircher A, Gamerith G, Amann A, Reinold S, Popper H, Gachter A, Pall G, Woll E, Jamnig H, Gastl G, Wolf AM, Hilbe W, Wolf D. Neoadjuvant chemo-immunotherapy modifies CD4(+)CD25(+) regulatory T cells (Treg) in non-small cell lung cancer (NSCLC) patients. Lung Cancer. 2014 Jul;85(1):81-7. doi: 10.1016/j.lungcan.2014.04.001. Epub 2014 Apr 13.

    PubMed 24780112

Questions about this trial

What is this clinical trial studying?

A study testing Reducing Excision Margins in people with Squamous Cell Carcinoma of Head and Neck and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 11 inclusion and 18 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 15 Jul 2022. 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.

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?

DFS（disease-free survival） (time frame: 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 NCT05459415, which also lists 17 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 15 Jul 2022.

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