RecruitingPhase 2NCT06208826

A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

268 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether immunotherapy maintenance (continued immunotherapy treatment after surgery) benefits patients with locally advanced head and neck squamous cell carcinoma who responded exceptionally well to pre-surgery immunotherapy plus chemotherapy. The goal is to prevent the cancer from coming back. **You may be eligible if...** - You are between 18 and 80 years old - You have confirmed non-metastatic squamous cell carcinoma of the head and neck - You achieved a major pathological response (near-complete tumor shrinkage) after receiving immunotherapy and chemotherapy before surgery - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer has spread to distant organs - You did not have a major pathological response to pre-surgery treatment - You have autoimmune conditions that prevent immunotherapy use 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

Toripamab, IV, 240mg, every 3 weeks for 15 cycles

RADIATIONRadiation Therapy

Radiation Therapy

DRUGCisplatin

Chemotherapy agent


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06208826


Related Trials