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 range18 Years – 75 Years
SexALL
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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)
✓. 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.
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
. 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