Trastuzumab Based Therapy in HER2 Positive AGC

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.

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Key information

Conditions

Gastric Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
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;
Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
left ventricular ejection fraction(LVEF) more than 50 percents;
sufficient bone marrow, liver and renal function.

Exclusion criteria

received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
trastuzumab based adjuvant/neoadjuvant therapy;
treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.

Treatment and study plan

H+CT

Drug

All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Other names: trastuzumab plus chemotherapy

Primary outcomes

OS

Time frame: 8 years

OS was defined as time from the beginning of first line therapy to death
PFS

Time frame: 8 years

PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jan 18, 2017
Registry last updated: Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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