RecruitingPhase 2NCT06170710

Postoperative CCRT Followed by Immunotherapy in High-Risk LA HNSCC

Postoperative Concurrent Chemoradiotherapy Followed by Anti-PD-1 Antibody Maintenance Therapy in High-Risk Locally Advanced Head and Neck Squamous Cell Carcinoma


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

173 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial aims to evaluate whether the addition of anti-PD-1 antibody to adjuvant postoperative chemoradiotherapy could improve disease free survival in patients with high-risk locally advanced head and neck squamous cell carcinoma (HNSCC).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (a PD-L1 or PD-1 inhibitor) after surgery and radiation plus chemotherapy improves outcomes for patients with high-risk head and neck squamous cell carcinoma (cancer of the mouth, throat, or voice box). **You may be eligible if...** - You have confirmed squamous cell carcinoma of the oral cavity, throat, voice box, or related areas - Your cancer has one or more high-risk features (such as close surgical margins, spread beyond lymph nodes, or cancer invasion of nerves or blood vessels) - Your tumor expresses PD-L1 (a protein marker) with a combined positive score greater than 1 - You are in good general health (ECOG 0-1) and have adequate organ function - Pregnancy test is negative (if applicable) **You may NOT be eligible if...** - You have another active cancer (except cured skin cancer, cervical carcinoma in situ, or superficial bladder cancer) - You have an active infection - You have contraindications to immunotherapy or chemoradiotherapy 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

DRUGAnti-PD-1 monoclonal antibody

Postoperative CCRT followed by any anti-PD-1 monoclonal antibody of the following: Pembrolizumab, 200mg, Q3W or Nivolumab, 3mg/kg, Q2W or Tislelizumab,200mg,Q3W or Camrelizumab,200mg,Q3W or Sintilimab,200mg,Q3W or Toripalimab,240mg,Q3W

OTHERPostoperative CCRT

Postoperative chemoradiotherapy


Locations(1)

National Cancer Cencer/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06170710


Related Trials