Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01938105

Enrollment

Registered

2013-09-10

Start date

2013-07-31

Completion date

2016-06-30

Last updated

2013-09-26

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

Conditions

Locally Advanced Cervical Cancer

Keywords

Cervical cancer, Nimotuzumab, Intensity-modulated radiation therapy, Concurrent chemoradiotherapy

Brief summary

The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.

Interventions

OTHERNimotuzumab+chemoradiotherapy

Nimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed. \--------------------------------------------------------------------------------

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically or cytologically proven squamous cell cervical cancer * Stages IB2-IIIB according to FIGO Staging System * Age:18-75 * ECOG\<2 * Normal bone marrow function * Initial assessed and considered not candidates for operation * Signed study-specific consent form

Exclusion criteria

* Pregnant or lactating women * Patients with other malignancies * Patients who received radiotherapy or chemotherapy previously * Presence of uncontrolled life-threatening illness * Allergy to platinum or monoclonal antibody

Design outcomes

Primary

Measure	Time frame	Description
Treatment related toxicities	at 1 year	Acute and chronic toxicities.
Tumor response after preoperative treatment	assessed at 4-5 weeks after the completion of preoperative treatment	—

Secondary

Measure	Time frame
Progression-free survival	at 1 year
Overall survival	at 1 year

Countries

China

Contacts

Primary ContactHeming Lu, MS

gxheminglu@sina.com+86-771-218-6503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026