RecruitingPhase 2NCT04807140

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

57 participants

Start Date

Jul 8, 2021

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving an immunotherapy drug (toripalimab) alone, or combined with chemotherapy (carboplatin and nab-paclitaxel), before surgery for head and neck squamous cell cancer (HNSCC) can shrink tumors and improve the chance of complete removal. **You may be eligible if...** - You have been diagnosed with head and neck squamous cell carcinoma (confirmed by biopsy) - You are between 18 and 80 years old - Surgery with curative intent is planned - You are in good general health (ECOG 0-1) - You have measurable disease **You may NOT be eligible if...** - You have received prior treatment for this cancer - You have active autoimmune disease - You are pregnant or breastfeeding - You have significant organ dysfunction Talk to your doctor to see if this trial is right for you.

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

DRUGToripalimab, nab-paclitaxel, carboplatin

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.

DRUGToripalimab

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.

PROCEDURESurgical resection

Surgical therapy will be at the discretion of the treating surgeon per standard of care.


Locations(1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04807140


Related Trials