RecruitingPhase 2NCT04992559

A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC

A Phase II, Open-Label, Single-arm Study of Toripalimab As Consolidation Therapy After Postoperative Radiotherapy or Chemoradiotherapy in Patients With Head and Neck Squamous Cell Carcinomas (HNSCC)


Sponsor

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

Enrollment

41 participants

Start Date

Jun 22, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether toripalimab (a PD-1 immunotherapy drug) given after surgery and radiation/chemotherapy helps prevent head and neck squamous cell cancer from coming back in patients with locally advanced disease who have certain risk factors. **You may be eligible if...** - You had surgery for locally advanced head and neck squamous cell cancer with high-risk features - You completed postoperative chemoradiation no more than 2 months ago - You are 18–70 years old in good general health (ECOG 0–1) - Your blood counts, liver, and kidney function are adequate - You do not have active autoimmune disease - You have not previously received anti-PD-1 immunotherapy **You may NOT be eligible if...** - You have evidence of interstitial lung disease or active pneumonitis - You have an active serious infection - You have another invasive cancer diagnosed in the last 5 years - You have a known history of HIV, active hepatitis B or C, or active tuberculosis - You are pregnant, breastfeeding, or planning pregnancy during the trial - You have psychiatric conditions or substance abuse that would prevent compliance 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.

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Interventions

DRUGConsolidation Toripalimab

Toripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months.


Locations(2)

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

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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NCT04992559


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