Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT07601737
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nimotuzumab Injection — DRUG
    Nimotuzumab 400mg，d3，Q3W，for two cycles。
  • Tislelizumab — DRUG
    tislelizumab (or pembrolizumab) 200mg，d1，Q3W，for two cycles。
  • Albumin-Bound Paclitaxel /nab-Paclitaxel — DRUG
    Albumin-bound paclitaxel 180 mg/m² (or docetaxel 75 mg/m²), administered on day 3, every 3 weeks (Q3W);for two cycles。
  • Cisplatin (Or Carboplatin) — DRUG
    Cisplatin 75 mg/m² (carboplatin AUC=5 may be substituted if cisplatin is not tolerated), administered on day 3, every 3 weeks (Q3W).for two cycles。
  • Radical surgery of tumor — PROCEDURE
    Standard radical surgery of tumor
  • Concurrent chemoradiotherapy — RADIATION
    Concurrent chemoradiotherapy： Radiotherapy: intensity modulated conformal radiotherapy (IMRT) was used with a total dose of 60-66gy (2gy/f, 30-33f). Chemotherapy: Cisplatin 40 mg/m2, QW, 6-7 times in total; Targeting: nimotuzumab 200mg, QW, 6-7 times in total.

Study Details

This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.

Key Dates

First listed
May 22, 2026
Start date
Apr 20, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group
    1. Nimotuzumab ,Albumin-bound paclitaxel and cisplatin administration on days 3 and 24, tislelizumab (or pembrolizumab) administration on days 1 and 22; 2. Standard of care surgery
  • Active Comparator: Control Group
    1.Standard of care surgery

Primary Outcome Measure

2-Year Event-Free Survival (EFS) Rate [ Time Frame: From first study treatment up to 2 years after the last patient randomized. ]

Central Contacts

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