RecruitingPhase 2NCT07353723

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

A Pilot Study to Assess Feasibility and Preliminary Efficacy of Neoadjuvant Nimotuzumab, Toripalimab, and Chemotherapy in Locally Advanced Tonsillar Cancer


Sponsor

Tang-Du Hospital

Enrollment

10 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective,single-arm,Phase II clinical study to designed to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of nimotuzumab (a targeted drug), toripalimab (an immunotherapy), and chemotherapy as a treatment before surgery for locally advanced tonsil cancer. Researchers want to see if this combination can shrink the tumor, improve surgery outcomes, and potentially increase survival. **You may be eligible if:** - You are aged 18 to 80 - You have been confirmed by biopsy to have locally advanced tonsil squamous cell carcinoma that can be surgically removed - Your general health status is good (ECOG performance status 0–2) - You have at least one measurable tumor on scans - Your blood counts, liver, kidney, and heart function are within acceptable ranges - You are willing to use effective contraception during and after treatment - Your expected survival is at least 6 months **You may NOT be eligible if:** - You have previously received systemic treatment for this cancer - You have received prior immunotherapy (anti-PD-1/PD-L1) or EGFR-targeted drugs - You have active autoimmune disease requiring treatment - You have a serious infection, HIV, active tuberculosis, or a history of serious lung inflammation - You have had major surgery within the past 30 days - You are pregnant or breastfeeding - Your cancer has spread to the brain 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

DRUGNimotuzumab

treatment Regimen:Nimotuzumab was administered by intravenous infusion at a dose of 400 mg,d1, Q3W,for 2-4 cycles Other Name:

DRUGToripalimab

treatment Regimen:Toripalimab was administered by intravenous infusion at a dose of 240 mg,d1,Q3W,for 2-4 cycles

DRUGNab-paclitaxel

treatment Regimen:Nab-paclitaxel was administered by intravenous infusion at a dose of 260mg/m² ,d1, Q3W,for 2-4 cycles

DRUGcarboplatin

treatment Regimen: Carboplatin dosage was calculated using the Calvert formula (dose = target AUC × \[GFR + 25\]), d1,IV,Q3W,for 2-4 cycles


Locations(1)

Tangdu Hospital, Air Force Medical University, Xi'an 710038, Shaanxi Province, China

Shanxi, Province, China

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NCT07353723


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