Neoadjuvant and Adjuvant Toripalimab and Cetuximab in Patients With Recurrent, Resectable Squamou… (NCT05586100) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant and Adjuvant Toripalimab and Cetuximab in Patients With Recurrent, Resectable Squamous Cell Carcinoma of Head and Neck: a Prospective, Single-arm,Phase II Study
China52 participantsStarted 2022-10-13
Plain-language summary
This study is the first clinical study of Neoadjuvant and Adjuvant treatment of head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with PD-1 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.
Who can participate
Age range
18 Years – 75 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 18-75 years old, regardless of gender
. histologically or cytologically confirmed and surgically curable recurrent localized squamous carcinoma of the head and neck (tumor primary sites are oropharynx, oral cavity, hypopharynx, and larynx) without any antitumor systemic therapy during the recurrent stage (allowed as part of treatment for locally advanced tumors and requiring more than 6 months between the end of treatment and the signing of the informed consent)
. an ECOG score of 0 or 1.
. an expected survival of ≥ 12 weeks.
. have at least one measurable lesion according to RECIST 1.1 criteria, and a previously treated lesion with radiation therapy, if disease progression has occurred, may also be a measurable lesion.
. availability of tumor tissue for PD-L1 detection (paraffin specimens less than 2 years old or fresh tumor tissue)
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
One-year events-free survival rate
Timeframe: 12 months
Trial details
NCT IDNCT05586100
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
. patients with oropharyngeal carcinoma provide a test status for P16, using the IHC method.
. Organ function levels must meet the following requirements (14 days prior to the first dose of study drug):
Exclusion criteria
. with distant metastatic lesions or localized lesions not indicated for surgery (patients with stage IVb or IVc)
. have progressed within 6 months after systemic therapy directed at locally advanced squamous head and neck cancer.
. a prior history of primary nasopharyngeal cancer tumor.
. patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of the study drug.
. underwent/received major surgery or have not recovered from the side effects of such surgery, live vaccination, immunotherapy within 4 weeks prior to the first dosing of the study drug, and radiation therapy within 2 weeks.
. receiving any other concurrent antitumor therapy.
. the patient has any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; vitiligo that does not require systemic therapy may be included; asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; patients requiring bronchial (asthma that requires medical intervention with bronchodilators cannot be included).
. patients who are on immunosuppressive, or systemic hormone therapy for immunosuppressive purposes (doses \>10 mg/day of prednisone or other equipotent hormones) and continue to use them within 2 weeks prior to enrollment