Neoadjuvant Chemotherapytreatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT05522985 | Active Not Recruiting Phase 2

• 1 other identifier: TJCIHMF&ENT-002
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of research is to evaluate the efficacy and safety of treprizumab injection combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (treprizumab injection combined with AP protocol) and the control group (TP protocol); The patients in both groups were treated with three cycles of induction therapy. After the induction therapy, the patients were evaluated and followed up with surgery.

Conditions

Head and Neck Squamous Cell Carcinoma; Neoadjuvant Chemotherapy

Keywords

Head and neck squamous cell carcinoma; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• PCR

  Pathological complete response rate

  9 weeks

Secondary Outcomes (1)

• MPR

  9 weeks

Other Outcomes (3)

• ORR

  9 weeks

• OS

  2 years

• PFS

  2 years

Study Arms (2)

Treprizumab combined with TP

EXPERIMENTAL

treprizumab injection: 240mg once, intravenous infusion, D1, once every 3 weeks, a total of 3 cycles. paclitaxel for injection (albumin binding type) 260 mg / m2, intravenous drip, D1, every 3 weeks as a cycle, a total of 3 cycles; cisplatin: 75mg / m2, intravenous drip, D1, once every 3 weeks, a total of 3 cycles; Treprizumab was infused before and at least 60 minutes apart from chemotherapy; The intravenous infusion time of treprizumab shall be at least 60 minutes. Intravenous bolus or single rapid intravenous injection is not allowed.

Drug: Triprilimab combined with TP

TP（paclitaxel +cisplatin）

ACTIVE COMPARATOR

paclitaxel for injection (albumin binding type) 260 mg / m2, intravenous drip, D1, every 3 weeks as a cycle, a total of 3 cycles; cisplatin: 75mg / m2, intravenous drip, D1, once every 3 weeks, a total of 3 cycles;

Drug: Triprilimab combined with TP

Interventions

Triprilimab combined with TP DRUG

Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.

TP（paclitaxel +cisplatin）; Treprizumab combined with TP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has head and neck squamous cell carcinoma confirmed by histopathology or cytology.
• Resectable, clinical stage III or IV and no distant metastasis (AJCC 8th)
• Initial treatment patients who have not received chemotherapy, radiotherapy, immunotherapy or biological therapy.
• There is at least one measurable lesion (RECIST 1.1 standard, see Annex 1).
• ECoG score: 0-1.
• Expected survival time ≥ 3 months.
• The functions of important organs meet the following requirements (no blood component, cell growth factor, white blood medicine, platelet medicine and anemia correction medicine are allowed to be used within 14 days before the first use of the study drug);WBC≥3.0x109 /L，ANC≥2.0x109/L,HB≥90g/L, Platelets ≥ 100x109 / L,Serum albumin ≥ 2.8g/dl,Total bilirubin ≤ 1.5xuln, ALT and AST ≤ 3.0xuln,Serum creatinine ≤ 1.5xuln or creatinine clearance rate \> 60ml / min (Cockcroft Gault, see Appendix 4),Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5xuln (for anticoagulant therapy using stable doses such as low molecular weight heparin or warfarin and INR can be screened within the expected therapeutic range of anticoagulants)
• No contraindications of chemotherapy and immunotherapy.
• No history of immune related diseases.
• No uncontrollable pneumonia and pulmonary infection.
• Subjects of childbearing age must agree to take effective contraceptive measures during the trial; The serum or urine pregnancy test of women of childbearing age 72 hours before the start of chemotherapy must be negative.
• The subject has good compliance, can carry out treatment and follow-up, and voluntarily complies with the provisions of this study.

You may not qualify if:

• Patients with distant metastasis.
• There are uncontrolled serious medical diseases, such as complicated serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
• Patients with a history of allergy or allergic constitution to any component of monoclonal antibody drugs in the past.
• Uncontrollable cardiac clinical symptoms or diseases, such as heart failure above NYHA grade II or left ventricular ejection fraction (LVEF) \< 50% indicated by color Doppler echocardiography; Unstable angina pectoris; Myocardial infarction occurred within 1 year; Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 MS);
• Serious infection (CTC AE \> grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia and infection complications requiring hospitalization; Baseline chest imaging revealed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics).
• Unexplained fever \> 38.5 ° C occurred during the screening period and before the first administration (tumor fever can be included in the group according to the judgment of the investigator);
• Active autoimmune diseases and history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism, including but not limited to these diseases or syndromes); But does not include autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes using a stable dose of insulin; Patients with vitiligo or childhood asthma / allergy who have been cured and do not need any intervention after adulthood;
• Have a history of immune deficiency, including HIV test positive, or have other acquired and congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation.
• Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU / ml, or patients with active hepatitis C virus (HCV) should be excluded; Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA \< 500iu / ml), and cured hepatitis C patients can be included in the group.
• Have a history of interstitial lung disease (excluding radiation pneumonia without hormone treatment) and non-infectious pneumonia.
• Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year before but without formal treatment.
• Patients who have received any of the following treatments;1)Received any investigational drug within 4 weeks before the first use of investigational drug; 2) Receive the last dose of anticancer treatment (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks before the first use of the study drug;3)Subjects who need to be given corticosteroids (\> 10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergy, nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenocortical hormone replacement at doses \> 10 mg / day prednisone efficacy dose were allowed ;4) Those who have been vaccinated with anti-tumor vaccine or have been vaccinated with live vaccine within 4 weeks before the first administration of the study drug; 5) Major surgery or severe trauma within 4 weeks before the first use of study drug; 6) Another clinical study was also included.
• There is dementia, mental state change or any mental illness that will hinder understanding or making informed consent or filling out questionnaires.
• subjects with ≥ grade 2 peripheral neuropathy according to CTCAE V5.0;
• History of allergy or hypersensitivity to any therapeutic ingredient.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 31, 2022
• Study Start: November 7, 2021
• Primary Completion: November 7, 2025
• Study Completion (Estimated): November 7, 2027
• Last Updated: January 13, 2026

Record last verified: 2025-10

Locations

CN (1)