Neoadjuvant Toripalimab or Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated HNSCC (HNSCC-002)
An Open Label, Two Arm Phase II Study of Toripalimab Versus Toripalimab in Combination With Carboplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for HNSCC
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
57 participants
Jul 8, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients receive Toripalimab IV on day 1, nab-paclitaxel IV on day 1 and carboplatin IV on day 1. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive Toripalimab IV on day 1. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity.
Surgical therapy will be at the discretion of the treating surgeon per standard of care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04807140