Trastuzumab Based Therapy in HER2 Positive AGC

Last updated: January 21, 2017
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Completed

Phase

N/A

Condition

Adenocarcinoma

Stomach Cancer

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT03024450
ZS-ON-08
  • Ages > 18
  • All Genders

Study Summary

Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;

  2. received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;

  3. with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;

  4. Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;

  5. left ventricular ejection fraction(LVEF) more than 50 percents;

  6. sufficient bone marrow, liver and renal function.

Exclusion

Exclusion Criteria:

  1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvantchemotherapy completed at least 6 months before enrollment);

  2. trastuzumab based adjuvant/neoadjuvant therapy;

  3. treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);

  4. patients with heart failure, coronary artery disease or myocardial infarction withinthe previous 6 months.

  5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnosesof AGC.

Study Design

Total Participants: 98
Study Start date:
January 01, 2012
Estimated Completion Date:
December 31, 2016

Study Description

A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Connect with a study center

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

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