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)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 335
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
Overview
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),
Detailed Description
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), The study aims to evaluate the efficacy and safety of radiotherapy combined with nimotuzumab in platinum-ineligible patients with (LA-HNSCC).Around 70 study sites were involved in the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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);
Exclusion Criteria
- •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.
Arms & Interventions
Radiotherapy alone in LA-HNSCC
Intervention: intensity-modulated technique（IMRT） (Radiation)
Radiotherapy plus nimotuzumab
radiotherapy plus nimotuzumab
Intervention: Nimotuzumab (Drug)
Radiotherapy plus nimotuzumab
radiotherapy plus nimotuzumab
Intervention: intensity-modulated technique（IMRT） (Radiation)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: 24 months after treatment initiation
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).
Secondary Outcomes
- 2-year locoregional control (LRC) 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)
- 2-year distant metastasis rate.(24 months after treatment initiation)
- Quality of Life (QoL)(24 months after treatment initiation)
Investigators
Man Hu
Shandong First Medical University Affiliated Cancer Hospital
Shandong Cancer Hospital and Institute