Head and Neck Squamous Cell CarcinomaPhase 2NCT07601737
Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Nimotuzumab Injection, Tislelizumab and Albumin-Bound Paclitaxel /nab-Paclitaxel in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma (HNSCC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Head & Neck Cancer
- What is being tested?
- Nimotuzumab Injection, Tislelizumab and Albumin-Bound Paclitaxel /nab-Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 30 Apr 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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:
- Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN
- 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.
- Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai First People's Hospital
Shanghai
xin wei chen, 86+18616017916, xinwei.chen@shgh.com
About this study
Official title: A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With Immunotherapy 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Head & Neck Cancer, Neoadjuvant Therapy
- Being tested
- Nimotuzumab Injection, Tislelizumab, Albumin-Bound Paclitaxel /nab-Paclitaxel, Cisplatin (Or Carboplatin), Radical surgery of tumor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab InjectionDrug
Also called Nimotuzumab
Nimotuzumab 400mg，d3，Q3W，for two cycles。
TislelizumabDrug
Also called pembrolizumab
tislelizumab (or pembrolizumab) 200mg，d1，Q3W，for two cycles。
Albumin-Bound Paclitaxel /nab-PaclitaxelDrug
Also called docetaxel
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
Also called Cisplatin, 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。
Radical surgery of tumorProcedure or surgery
Standard radical surgery of tumor
Concurrent chemoradiotherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Radical surgery of tumor; Radiation: Concurrent chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Event-Free Survival (EFS) Rate
Measured: From first study treatment up to 2 years after the last patient randomized.
Secondary outcomes (5)
Major Pathologic Response (MPR)
Measured: Within 4 weeks after surgery.
Pathological Complete Response (pCR)
Measured: Within 4 weeks after surgery.
Objective Response Rate (ORR)
Measured: After 2 cycles (each cycle is 21 days） of neoadjuvant treatment.
2-Year Overall Survival (OS) Rate
Measured: From first study treatment up to 2 years after the last patient randomized.
Quality of Life (QoL)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pin Dong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601737
- Sponsor's protocol ID
- IIT-Nim-HNSCC-03
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No