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Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma

NCT02370849 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-02-25

No results posted yet for this study

Summary

In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group.

The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

nimotuzumab

nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks

DRUG

cisplatin

cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks

DRUG

S-1

S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Yihebali Chi, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-02-29
Completion
2015-02-28

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 NCT02370849 on ClinicalTrials.gov