Active — Not RecruitingPhase 2

Neoadjuvant Chemotherapytreatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

China122 participantsStarted 2022-07-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria： * 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 te…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PCR

Timeframe: 9 weeks

Trial details

NCT IDNCT05522985

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-07

View on ClinicalTrials.gov More Head and Neck Squamous Cell Carcinoma trials