Toripalimab-based Neoadjuvant Therapy in LA-HNSCC (NCT05522985) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Toripalimab-based Neoadjuvant Therapy in LA-HNSCC
China122 participantsStarted 2022-09-02
Plain-language summary
The objective of research is to evaluate the efficacy and safety of Toripalimab 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 (Toripalimab combined with AP ) and the control group (AP ); 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
. Age ≥ 18 years, male or female;
. Patients with squamous cell carcinoma of head and neck confirmed by histopathology or cytopathology;
. Surgical resection available, clinical stage III or IV without distant metastasis (AJCC 8th)
. Patients who have not received any prior anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy or biological therapy;
. At least one measurable lesion according to RECIST 1.1 (Appendix 1)
. ECOG performance status 0-1 (Appendix 2);
. Expected survival ≥3 months;
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
1
PCR
Timeframe: 12 weeks
Trial details
NCT IDNCT05522985
SponsorTianjin Medical University Cancer Institute and Hospital
. Function of vital organs meets the following requirements (no blood component, cell growth factor, white blood cell-raising drug, platelet-raising drug, and blood correction drug is allowed within 14 days prior to the first dose of study drug); A.WBC≥3.0x109 /L, ANC≥2.0x109/L B.HB≥90g/L C.Platelets ≥ 100 × 10 9/L D.Serum albumin ≥2.8 g/dL E.Bilirubin total ≤ 1.5 x ULN, ALT ≤ 3.0 x ULN F.Serum creatinine ≤ 1.5xULN or Creatinine clearance \> 60 mL/min G.Activated partial thromboplastin time (APTT) and International normalized ratio (INR) ≤ 1.5 x ULN (screening is allowed for stable doses of Anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants)
Exclusion criteria
. Patients with distant metastasis;
. Uncontrolled severe medical diseases, e.g., severe heart disorder (New York Heart Association class II or higher; Appendix 3), cerebrovascular angiopathy, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc., combined with these medical diseases;
. Previous history of allergy to any component of monoclonal antibody or allergic constitution;
. Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher Cardiac failure or left ventricular Ejection fraction (LVEF) \<50% as indicated by cardiac echocardiography, Angina unstable, Myocardial infarction within 1 year, patients with clinically significant supraventricular or Ventricular arrhythmia requiring clinical intervention (including QTc interval ≥ 470 ms);
. Serious infection (NCI CTCAE \> Grade 2) occurred within 4 weeks before the first dose of the study drug, such as severe pneumonia, bacteraemia, and infectious complications requiring hospitalisation; Baseline chest imaging suggests active pneumonitis, symptoms and signs of infection within 2 weeks before the first dose of the study drug, or oral or intravenous antibiotic therapy is required for treatment (excluding the use of antibiotics for prophylaxis);
. Unexplained fever \>38.5℃ occurred during the screening period and prior to the first dose (tumor fever judged by the investigator could be enrolled);
. Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones; type I diabetes mellitus treated with stable doses of insulin; vitiligo or healed childhood asthma/allergy that does not require any intervention after adulthood;
. History of immunodeficiency, including HIV-positive test, or other acquired, immunodeficiency congenital diseases, or history of organ transplant and allogeneic bone marrow transplant;