MedTrace Logo

Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma

NCT02611700 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2016-02-01

No results posted yet for this study

Summary

This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.

Conditions

  • Esophageal Squamous Cell Carcinomas

Interventions

DRUG

Nimotuzumab

400mg,day1,weekly,until disease progression or toxicity

DRUG

Paclitaxel

175mg/m\^2,for 3 hour(Peripherally Inserted Central Catheter,PICC),day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.

DRUG

Cisplatin

60mg/m\^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.

DRUG

Placebo

400mg,day1,weekly,until disease progression or toxicity

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Lin Shen, Dr · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611700 on ClinicalTrials.gov