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

ConditionsHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma (HNSCC)Head & Neck CancerNeoadjuvant Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Study GroupExperimental treatment 6 interventions
Group B: Control GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

2-Year Event-Free Survival (EFS) Rate

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

Secondary outcomes

1

Major Pathologic Response (MPR)

Time frame
Within 4 weeks after surgery.
2

Pathological Complete Response (pCR)

Time frame
Within 4 weeks after surgery.
3

Objective Response Rate (ORR)

Time frame
After 2 cycles (each cycle is 21 days） of neoadjuvant treatment.
4

2-Year Overall Survival (OS) Rate

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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