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

NCT07601737 | Recruiting Phase 2

• 1 other identifier: IIT-Nim-HNSCC-03
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma (HNSCC); Head & Neck Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• 2-Year Event-Free Survival (EFS) Rate

  From first study treatment up to 2 years after the last patient randomized.

Secondary Outcomes (5)

• Major Pathologic Response (MPR)

  Within 4 weeks after surgery.

• Pathological Complete Response (pCR)

  Within 4 weeks after surgery.

• Objective Response Rate (ORR)

  After 2 cycles (each cycle is 21 days） of neoadjuvant treatment.

• 2-Year Overall Survival (OS) Rate

  From first study treatment up to 2 years after the last patient randomized.

• Quality of Life (QoL)

  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

Study Arms (2)

Study Group

EXPERIMENTAL

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; Drug: Tislelizumab; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Cisplatin (Or Carboplatin); Procedure: Radical surgery of tumor; Radiation: Concurrent chemoradiotherapy

Control Group

ACTIVE COMPARATOR

1.Standard of care surgery

Procedure: Radical surgery of tumor; Radiation: Concurrent chemoradiotherapy

Interventions

Nimotuzumab Injection DRUG

Nimotuzumab 400mg，d3，Q3W，for two cycles。

Also known as: Nimotuzumab

Study Group

Tislelizumab DRUG

tislelizumab (or pembrolizumab) 200mg，d1，Q3W，for two cycles。

Also known as: pembrolizumab

Study Group

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。

Also known as: docetaxel

Study Group

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。

Also known as: Cisplatin, carboplatin

Study Group

Radical surgery of tumor PROCEDURE

Standard radical surgery of tumor

Control Group; Study Group

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.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years inclusive.
• 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.
• Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• 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.
• Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required).
• At least one measurable lesion per RECIST 1.1.
• Life expectancy ≥ 6 months.
• 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
• 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))
• Adequate hepatic function:

You may not qualify if:

• Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.
• Participation in another interventional clinical trial within 30 days prior to screening.
• In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.
• Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.
• History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin).
• History of primary immunodeficiency disease.
• Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc.
• Known HIV infection, active viral hepatitis, or active tuberculosis.
• Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment.
• Hypersensitivity to any study drug or their components.
• 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).
• Investigator considers the subject not suitable for study participation.
• Unwilling to participate or unable to provide written informed consent.
• Receipt of a live vaccine within 30 days before the first study drug administration.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai First People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

nimotuzumab; tislelizumab; pembrolizumab; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Docetaxel; Cisplatin; Carboplatin; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

xin wei chen

CONTACT

86+18616017916; xinwei.chen@shgh.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)