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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05459415
Other study ID # REMATCH2201
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 22, 2022
Est. completion date June 21, 2027

Study information

Verified date June 2022
Source Wuhan Union Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 54
Est. completion date June 21, 2027
Est. primary completion date June 21, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Age is 18-70 years old, gender is unlimited; 2. Histological diagnosis of oral, oropharyngeal, hypopharyngeal, or laryngeal squamous cell carcinoma; preoperative evaluation can be surgical resection. 3. 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; 4. According to the RECIST version 1.1 standard, With at least one evaluable target lesion; 5. the ECOG physical status is 0-1 points; 6. 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); 7. Signed written informed consent prior to any test-related activity; 8. Investigators judged the ability to comply with the study protocol; 9. pregnancy test at screening (for fertile female patients) negative; 10. 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. 11. 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 Exclusion Criteria: 1. 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. 2. Major surgery for the first 4 weeks before enrollment; 3. People with a proven allergy to PD-1 antibody or its excipients; 4. 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); 5. 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); 6. 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; 7. 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; 8. Active infection requiring treatment; 9. 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); 10. Patients have received other oncology treatments before treatment; 11. Live vaccine within 4 weeks before the start of study treatment; 12. Known history of psychotropic substance abuse, alcohol or drug use; 13. Women during pregnancy or lactation; 14. 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; 15. Patients considered not feasible for radical resection; 16. active tuberculosis; 17. 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); 18. 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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Reducing Excision Margins
Reducing Excision Margins After Neoadjuvant Chemoimmunotherapy

Locations

Country Name City State
China Zhanjie Zhang Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (17)

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 Ca — View Citation

Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M, de Castro G Jr, Psyrri A, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesía R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, González Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD — View Citation

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 — View Citation

Cohen EE, Karrison TG, Kocherginsky M, Mueller J, Egan R, Huang CH, Brockstein BE, Agulnik MB, Mittal BB, Yunus F, Samant S, Raez LE, Mehra R, Kumar P, Ondrey F, Marchand P, Braegas B, Seiwert TY, Villaflor VM, Haraf DJ, Vokes EE. Phase III randomized tri — View Citation

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. Review. — View Citation

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 — View Citation

Gandhi L, Rodríguez-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, — View Citation

Lacas B, Carmel A, Landais C, Wong SJ, Licitra L, Tobias JS, Burtness B, Ghi MG, Cohen EEW, Grau C, Wolf G, Hitt R, Corvò R, Budach V, Kumar S, Laskar SG, Mazeron JJ, Zhong LP, Dobrowsky W, Ghadjar P, Fallai C, Zakotnik B, Sharma A, Bensadoun RJ, Ruo Redd — View Citation

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-c — View Citation

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. — View Citation

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. Review. — View Citation

Pircher A, Gamerith G, Amann A, Reinold S, Popper H, Gächter A, Pall G, Wöll 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. L — View Citation

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/caa — View Citation

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 Ne — View Citation

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 h — View Citation

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, fl — View Citation

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. d — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other ORR tumor objective response rate 2 years
Other pCR Pathologic Complete Response 2 years
Primary DFS(disease-free survival) 2 years disease-free survival 2 years
Secondary Organ retention rate Organ retention rate 2 years
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