Randomized, double-blind, phase III study comparing nituzumab combined with chemoradiotherapy versus chemoradiotherapy alone in locally advanced hypopharyngeal squamous cell carcinoma

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100043851

Enrollment

Unknown

Registered

2021-03-04

Start date

2021-03-03

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous cell carcinoma of the hypopharynx

Interventions

experimental group:Nituzumab concurrent chemoradiotherapy

control group:chemoradiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologic squamous cell carcinoma stage III/IV head and neck carcinoma; 2. Aged 18 - 70 years; 3. KPS score 90 or higher; 4. Through pathological histology and cytology diagnose III - IV phase of head and neck squamous cell carcinomas (except nasopharyngeal carcinoma), the expression of EGFR positive.

Exclusion criteria

Exclusion criteria: 1. Participation in other interventional clinical trials within 30 days was screened; 2. Patients with distant; 3. A history of other malignanciesmetastasis; 4. Known to be infected with HV virus or active viral hepatitis; 5. People who are allergic to drugs or other ingredients used in this program; 6. Patients considered by the investigator to be ineligible for participation in this study.

Design outcomes

Primary

Measure	Time frame
2 years total survival (os) rate;2 year progression-free survival (PFS) rate;Objective remission rate (ORR);Median totale survival (OS);Medina progression-free survival (PFS);living quality;	—

Countries

China

Contacts

Public ContactHao Chuncheng

Harbin Medical University Affiliated Tumor Hospital

Haochuncheng1980@163.com+86 18245117029

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026