[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621536":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":38,"collaborators":31,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":31,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":64,"whyStopped":31,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":31},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab monotherapy","EXPERIMENTAL","Participants receive two 3-week cycles of toripalimab 240 mg IV before undergoing radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.",[13],"Drug: Toripalimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Toripalimab + chemotherapy","Participants receive two 3-week cycles of toripalimab 240 mg IV combined with docetaxel 75 mg\u002Fm² and cisplatin 75 mg\u002Fm² before radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.",[18,13],"Drug: Docetaxel and Cisplatin",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Docetaxel and Cisplatin","Neoadjuvant chemotherapy: docetaxel 75 mg\u002Fm² IV Day 1 + cisplatin 75 mg\u002Fm² IV Day 1, repeated every 21 days for 2 cycles, given together with toripalimab in the combination arm.",[15],[26],"Taxotere；Platinol",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Toripalimab","Humanised anti-PD-1 IgG4κ monoclonal antibody. 240 mg IV infusion Day 1 of each 21-day cycle for 2 neoadjuvant cycles, then 3 cycles concurrent with post-op radiotherapy\u002Fchemoradiotherapy, followed by 12 adjuvant cycles every 3 weeks.",[15,9],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Xuekui Liu, MD, PhD","CONTACT","：020-87343009","liuxuek@sysucc.org.cn",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Xuekui Liu","Chief Physician, Department of Head and Neck Surgery, Sun Yat-sen University Cancer Center; Principal Investigator of the SHINE Study","100621536","phase-3-toripalimab--chemo-as-neoadjuvant-therapy-in-la-hnscc-a-phase-iii-trial-100621536",false,"NCT07371897","Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial","A Randomized, Open-label, Multi-center Phase III Clinical Study of Toripalimab Combined With Cisplatin and Docetaxel Versus Toripalimab Alone as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma","SHINE","Inclusion Criteria:\n\n* Pathologically confirmed, newly diagnosed, non-metastatic, operable locally advanced head-and-neck squamous cell carcinoma (oral cavity, larynx, hypopharynx, or oropharynx) Stage III-IVA (p16-positive oropharynx T4N0-N2; p16-negative oropharynx III-IVA; larynx\u002Fhypopharynx\u002Foral cavity III-IVA) PD-L1 CPS ≥ 1 Age 18-70 years ECOG performance status 0-1 Adequate organ function (ANC ≥ 2.0×10⁹\u002FL, platelets ≥ 100×10⁹\u002FL, TBIL \\\u003C 1.5×ULN, ALT\u002FAST \\\u003C 1.5×ULN, creatinine \\\u003C 1.5×ULN) No prior head-and-neck cancer surgery or radiotherapy No other malignancy within 5 years Signed informed consent\n\nExclusion Criteria:\n\n* Previous systemic anti-cancer therapy for head-and-neck cancer Known hypersensitivity to study drugs Active or untreated hepatitis B\u002FC, HIV positivity Severe cardiac, pulmonary, liver, or renal insufficiency precluding surgery Pregnancy or lactation Psychiatric or social conditions preventing compliance Organ transplant on chronic immunosuppression","ALL","18 Years","70 Years",{"count":54,"type":55},154,"ESTIMATED","INTERVENTIONAL",[58],"PHASE3","This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.\n\nEligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).\n\nWe will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.\n\nTaking part is voluntary and you can leave the study at any time.",[61],"Head and Neck Squamous Cell Carcinoma HNSCC",[63],"Head and Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-01-19",{"date":67,"type":68},"2026-01-28","ACTUAL",{"date":70,"type":55},"2026-06-30",{"date":72,"type":55},"2026-09-30",{"name":5,"class":6}]