Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07353723

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

Led by Tang-Du Hospital · Updated on 2026-01-20

10

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old inclusive
  • Diagnosed with resectable locally advanced tonsillar squamous cell carcinoma confirmed by pathology and MRI
  • At least one measurable lesion by RECIST Version 1.1
  • Male participants agree to comply with contraception or abstinence during and up to 180 days after chemotherapy
  • Female participants are not pregnant or breastfeeding and agree to use effective contraception or abstain during and up to 210 days after chemotherapy
  • ECOG Performance Status 0-2 within 3 days before first treatment
  • Evidence of extranodal extension in lymph nodes confirmed by MRI, CT, or pathology
  • Voluntarily sign informed consent
  • Expected survival of at least 6 months
  • Adequate organ function based on blood counts, kidney, liver, and coagulation tests
  • Good compliance and willingness to cooperate with follow-up
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for advanced or unresectable tonsillar cancer except permitted neoadjuvant/adjuvant therapy completed at least 6 months prior
  • Active autoimmune disease requiring systemic therapy within past 2 years
  • Major surgery with inadequate recovery before study treatment
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or EGFR-targeted agents
  • Anti-tumor therapy or investigational drugs within 4 weeks before enrollment
  • Unresolved adverse events from prior cancer therapy greater than Grade 1
  • Radiotherapy within 2 weeks before study treatment without full recovery
  • Live vaccines within 30 days before first study drug dose
  • Participation in another investigational drug/device study within 4 weeks before first dose
  • Immunodeficiency or recent systemic corticosteroid or immunosuppressive therapy
  • History of invasive malignancy requiring treatment within past 3 years except certain skin and in situ cancers
  • Severe hypersensitivity to study drugs or their components
  • History or current pneumonitis requiring corticosteroids
  • Active infection requiring systemic therapy
  • Known HIV infection or active tuberculosis
  • Severe uncontrolled concurrent diseases
  • Major surgery within 30 days prior or planned during study
  • CNS metastases or carcinomatous meningitis
  • Psychiatric illness or substance abuse interfering with compliance
  • History of allogeneic tissue or organ transplant
  • Unwillingness or inability to consent or participate in study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Shanxi, Province, China

Actively Recruiting

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Research Team

Z

Zhao DaQing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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