Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

NCT07333274 | Recruiting Phase 3

• 1 other identifier: IST-Nim-HNSCC-45
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),

Conditions

Head & Neck Squamous Cell Carcinoma; Head & Neck Cancer

Keywords

Nimotuzumab; Radiotherapy; locoregionally advanced head and neck squamous cell carcinoma; LA-HNSCC

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  the proportion of patients in a clinical study who remain free of disease progression (including local recurrence, regional lymph node metastasis, distant metastasis, or second primary malignancy) and have not died from any cause within 2 years from the start of treatment (or randomization in randomized controlled trials).

  24 months after treatment initiation

Secondary Outcomes (5)

• 2-year locoregional control (LRC) rate.

  24 months after treatment initiation

• 2-year distant metastasis rate.

  24 months after treatment initiation

• Overall Survival (OS)

  24 months after treatment initiation

• Objective Response Rate (ORR; CR+PR by RECIST 1.1).

  24 months after treatment initiation

• Quality of Life (QoL)

  24 months after treatment initiation

Study Arms (2)

Radiotherapy plus nimotuzumab

EXPERIMENTAL

radiotherapy plus nimotuzumab

Drug: Nimotuzumab; Radiation: intensity-modulated technique（IMRT）

Radiotherapy alone in LA-HNSCC

ACTIVE COMPARATOR

Radiation: intensity-modulated technique（IMRT）

Interventions

intensity-modulated technique（IMRT） RADIATION

Treatment regimen： Radiotherapy (both groups): intensity-modulated technique (photon IMRT or proton IMPT); total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.

Also known as: photon IMRT, proton IMPT, intensity-modulated technique

Radiotherapy alone in LA-HNSCC; Radiotherapy plus nimotuzumab

Nimotuzumab DRUG

Treatment regimen： Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).

Also known as: Nimotuzumab injection

Radiotherapy plus nimotuzumab

Eligibility Criteria

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

You may qualify if:

• Eligible subjects must meet all of the following:
• Age ≥18 years.
• Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).
• Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \[T3-4 N0-3 M0, or T1-2 N2-3 M0\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).
• Suitable for definitive radiotherapy with curative intent.
• At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:
• Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;
• ECOG Performance Status \>2 (if this criterion is met, the ECOG criterion listed below may be waived);
• Renal dysfunction: creatinine clearance (CrCl) \<50 mL/min (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);
• Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);
• Peripheral neuropathy \> Grade 1;
• Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.
• Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV/p16 testing if feasible (no need to retest if previously tested).
• ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).
• At least one measurable lesion per RECIST 1.1.

You may not qualify if:

• Any of the following excludes enrollment:
• Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.
• Participation in another interventional clinical trial within 30 days prior to screening.
• History of other malignancy (except cured basal cell carcinoma of the skin).
• History of primary immunodeficiency.
• Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).
• Known HIV infection, or active viral hepatitis or active tuberculosis.
• Major surgery within 90 days before first study treatment, or planned surgery during the study.
• Known allergy to nimotuzumab or its excipients.
• Deemed unsuitable to participate by the investigator.
• Unwilling or unable to sign informed consent.
• Receipt of a live vaccine within 30 days before first dose.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital

Shandong, Province, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Man Hu

  Shandong First Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Hu

CONTACT

86+15806698606; hu5770@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shandong First Medical University Affiliated Cancer Hospital

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 12, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2028
• Study Completion (Estimated): January 5, 2030
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)