Nimotuzumab (Taixinsheng) combined with radiotherapy and chemotherapy for protecting the laryngeal function of locally advanced hypopharyngeal and laryngeal cancer patients: a multi-center, single-blind, randomized, controlled, phase II study

Induction Chemotherapy Followed by radiotherapy combined with Nimotuzumab and Cisplatin/Docetaxel for Larynx Preservation: a Multicentor Randomized Phase II Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16007712

Enrollment

Unknown

Registered

2015-06-19

Start date

2013-02-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Hypopharyngeal cancer, laryngeal cancer

Interventions

group1:nimotuzumab (200mg) combine with Radiotherapy and Cisplatin

group2:nimotuzumab (200mg) combine with Radiotherapy and Docetaxel

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients have no previous malignancy and a histologically proven squamous cell carcinoma of the stage III-IV larynx or hypopharynx ( American Joint Committee disease stages). Eligibility criteria were age between 18 and 70 years, good performance status of ECOG (Eastern Cooperative Oncology Group) 0 or 1; life expectancy >=6 months; Adequate bone marrow, renal and hepatic function. No prior chemotherapy, radiotherapy,or surgery.

Exclusion criteria

Exclusion criteria: Patients with synchronous primary cancers or/and metastasis disease or/and received epidermal growth factor targeted therapy are excluded. All patients refused surgical management.

Design outcomes

Primary

Measure	Time frame
Larynx preservation;safety;	—

Secondary

Measure	Time frame
Local control survival;Disease-free survival;Disease-free survival;Overall survival;	—

Countries

China

Contacts

Public ContactXinxin Zhang

xinxinzhang66@hotmail.com+86 15910520109

Outcome results

None listed

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