Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

May 15, 2026 updated by: Pin Dong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 75 years inclusive.
  2. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition.
  3. Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  5. For oropharyngeal carcinoma: mandatory p16 immunohistochemistry (testing within standard of care is acceptable; repeat testing not required). p16 testing is not required for other tumor locations.
  6. Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required).
  7. At least one measurable lesion per RECIST 1.1.
  8. Life expectancy ≥ 6 months.

  9. Adequate hematologic function:

    White blood cell count ≥ 4.0 × 10⁹/L Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L

  10. Adequate renal function:

    Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR

    Creatinine clearance (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula:

    Female: CrCl (mL/min) = (140 - age) × body weight (kg) × 0.85 / (72 × serum creatinine (mg/dL)) Male: CrCl (mL/min) = (140 - age) × body weight (kg) × 1.00 / (72 × serum creatinine (mg/dL))

  11. Adequate hepatic function:

    Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN

  12. Female subjects: negative pregnancy test within 2 weeks before first study drug, non-lactating.

    Females: highly effective contraception required during study and for 6 months after last study drug.

    Males: highly effective contraception required during study and for 6 months after last study drug.

  13. Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements.

Exclusion Criteria:

  1. Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.
  2. Participation in another interventional clinical trial within 30 days prior to screening.
  3. In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.
  4. Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.
  5. History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin).
  6. History of primary immunodeficiency disease.
  7. Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc.
  8. Known HIV infection, active viral hepatitis, or active tuberculosis.
  9. Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment.
  10. Hypersensitivity to any study drug or their components.
  11. Pregnant (confirmed by serum or urine HCG test) or lactating woman; or subject of childbearing potential unwilling or unable to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment (applicable to both males and females).
  12. Investigator considers the subject not suitable for study participation.
  13. Unwilling to participate or unable to provide written informed consent.
  14. Receipt of a live vaccine within 30 days before the first study drug administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Nimotuzumab Injection
Nimotuzumab 400mg，d3，Q3W，for two cycles。
Other Names:
  • Nimotuzumab
Drug: Tislelizumab
tislelizumab (or pembrolizumab) 200mg，d1，Q3W，for two cycles。
Other Names:
  • pembrolizumab
Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
Albumin-bound paclitaxel 180 mg/m² (or docetaxel 75 mg/m²), administered on day 3, every 3 weeks (Q3W);for two cycles。
Other Names:
  • docetaxel
Drug: Cisplatin (Or Carboplatin)
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。
Other Names:
  • Cisplatin
  • carboplatin
Procedure: Radical surgery of tumor
Standard radical surgery of tumor
Radiation: Concurrent chemoradiotherapy

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.
Active Comparator: Control Group
1.Standard of care surgery
Procedure: Radical surgery of tumor
Standard radical surgery of tumor
Radiation: Concurrent chemoradiotherapy

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Pathologic Response (MPR)
Time Frame: Within 4 weeks after surgery.
Within 4 weeks after surgery.
Pathological Complete Response (pCR)
Time Frame: Within 4 weeks after surgery.
Within 4 weeks after surgery.
Objective Response Rate (ORR)
Time Frame: After 2 cycles (each cycle is 21 days） of neoadjuvant treatment.
After 2 cycles (each cycle is 21 days） of neoadjuvant treatment.
2-Year Overall Survival (OS) Rate
Time Frame: From first study treatment up to 2 years after the last patient randomized.
From first study treatment up to 2 years after the last patient randomized.
Quality of Life (QoL)
Time Frame: Baseline（Screening） After neoadjuvant chemotherapy：Study Group（S）Week6 /Control Group（C）NA Post-surgery：S Week 9/C Week 3 After adjuvant radiotherapy（S Week 21/C Week 15） End of treatment（Week 24） Follow-up: Month 6, Month 12, Month 24

Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires QLQ-C30 (V3.0).

EORTC QLQ-C30 V3.0：The scale consists of general domain items and global health and quality of life items. General domain items are further divided into functional domains and symptom domains. The raw scores of general items range from 1 (minimum) to 4 (maximum), while those of global health and quality of life items range from 1 (minimum) to 7 (maximum). All raw scores are finally standardized to scores ranging from 0 to 100.

In functional domains including PF, RF, EF, CF, SF and QL, higher scores indicate better functional status. In symptom domains including FA, NV, PA, DY, SL, AP, CO, DI and FI, higher scores stand for more severe symptoms. For the global health and quality of life domain, higher scores reflect better general health condition and quality of life.
Baseline（Screening） After neoadjuvant chemotherapy：Study Group（S）Week6 /Control Group（C）NA Post-surgery：S Week 9/C Week 3 After adjuvant radiotherapy（S Week 21/C Week 15） End of treatment（Week 24） Follow-up: Month 6, Month 12, Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-Nim-HNSCC-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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