OncoMatch/Clinical Trials/NCT04807140
Neoadjuvant Toripalimab or Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated HNSCC (HNSCC-002)
Is NCT04807140 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab, nab-paclitaxel, carboplatin and Toripalimab for head and neck squamous cell carcinoma.
Treatment: Toripalimab, nab-paclitaxel, carboplatin · Toripalimab — This proposed study will evaluate the efficacy and safety of preoperative administration of Toripalimab or Toripalimab combined with nab-paclitaxel and carboplatin in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery，and it will be helpful for comprehensive exploratory characterization of tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in HNSCC. We are also eager to identify potential biomarkers of response and toxicity that will enable patients with HNSCC who are most likely to benefit to receive anti-PD-1 therapy and, to the contrary, reduce the risk of toxicity and ineffective therapy in patients who are less likely to benefit from it.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune-mediated therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2)
Exception: therapeutic anticancer vaccines
no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 , anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 , or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines
Cannot have received: investigational agent
currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment
Cannot have received: systemic therapy, surgery, or radiation for another malignancy
has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0
Lab requirements
Blood counts
absolute neutrophil count >1,500/µl; platelets > 100 x 10^3/µl; hemoglobin > 9.0 g/dl
Kidney function
serum creatinine < 1.5 x uln or crcl > 40ml/min
Liver function
ast/alt ≤ 3 x uln; total bilirubin ≤ 1.5 x uln (except gilbert syndrome < 3.0 mg/dl)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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