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Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma

NCT03400592 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-01-17

No results posted yet for this study

Summary

The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

Irinotecan

180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

DRUG

nimotuzumab

400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-06-30
Completion
2018-06-30

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 NCT03400592 on ClinicalTrials.gov