Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Docetaxel and Cisplatin, Toripalimab.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma HNSCC. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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. Eligible 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). We 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. Taking part is voluntary and you can leave the study at any time.
Interventions
- Drug Docetaxel and Cisplatin
Neoadjuvant chemotherapy: docetaxel 75 mg/m² IV Day 1 + cisplatin 75 mg/m² IV Day 1, repeated every 21 days for 2 cycles, given together with toripalimab in the combination arm. - Drug 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/chemoradiotherapy, followed by 12 adjuvant cycles every 3 weeks.
Primary outcome measures
- 2-year Event-Free Survival [Time frame: From randomisation to 24 months]
- 2-year Event-Free Survival (EFS) [Time frame: From randomisation to 24 months]
Eligibility criteria
Inclusion criteria
- 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/hypopharynx/oral cavity III-IVA) PD-L1 CPS ≥ 1 Age 18-70 years ECOG performance status 0-1 Adequate organ function (ANC ≥ 2.0×10⁹/L, platelets ≥ 100×10⁹/L, TBIL < 1.5×ULN, ALT/AST < 1.5×ULN, creatinine < 1.5×ULN) No prior head-and-neck cancer surgery or radiotherapy No other malignancy within 5 years Signed informed consent
Exclusion criteria
- Previous systemic anti-cancer therapy for head-and-neck cancer Known hypersensitivity to study drugs Active or untreated hepatitis B/C, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07371897 · SYSUCC-HN-2024-SHINE