RecruitingPhase 2NCT06470217

Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma

A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel with Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma


Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Enrollment

116 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tirilizumab (an immunotherapy drug) combined with chemotherapy (albumin-bound paclitaxel and cisplatin) before surgery in people with resectable advanced mouth (oral cavity) cancer. **You may be eligible if...** - You are 18 to 75 years old with stage III-IVa squamous cell carcinoma of the oral cavity that can be surgically removed - Your tumor is measurable on a CT scan - Your ECOG score is 0 or 1 - Your expected survival is at least 12 weeks - Tumor tissue is available for PD-L1 testing - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - Your cancer is not surgically removable - You have serious heart, liver, or kidney problems - You have received prior treatment for this cancer - You are pregnant or breastfeeding 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

DRUGtirilizumab with albumin-bound paclitaxel and cisplatin

tirilizumab administered by intravenous drip (no prophylaxis required) at a fixed dose of 200 mg. each infusion was given for 30 min (not less than 20 min and not more than 60 min) every 3 weeks, and 3 preoperative cycles of albumin-bound paclitaxel 260 mg/m2 and cisplatin 75 mg/m2 on d1, with 1 cycle every 21 days; 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.

PROCEDUREsurgery

patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.


Locations(1)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06470217


Related Trials