Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT01612286

Last Updated: 2014-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasopharyngeal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

endostatin

chemotherapy concurrently with endostatin

Group Type EXPERIMENTAL

endostatin

Intervention Type DRUG

Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle \*4cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endostatin

Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle \*4cycles

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

endostar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed metastatic NPC patient who have received radiotherapy or chemoradiotherapy with an at least 6 months interval
* Have measurable lesions
* No dysfunction of the major organs
* Can understand this study and give a signed informed consent certificates
* without a history of allergic reaction to the biological agents

Exclusion Criteria

* Pregnant or lactating women; Women of child-bearing age without contraception
* with a Serious infection or dysfunction of the major organs
* have taken other antitumor drugs during the period of 30 days ahead of this clinical trial
* allergic to the Escherichia coli preparations
* Cann't understand this study and give a signed informed consent certificates
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bin Li

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Jin T, Li B, Chen XZ. A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286). Oncol Res. 2013;21(6):317-23. doi: 10.3727/096504014X13983417587401.

Reference Type DERIVED
PMID: 25198661 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZhejaingCH-npc-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.