Trastuzumab Based Therapy in HER2 Positive AGC

Completed

• Conditions: Gastric Adenocarcinoma
• Interventions: Drug: H+CT

• Registration Number: NCT03024450
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-18
• Last Update Submitted: 2017-01-21
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 Criteria

1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy 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 within the previous 6 months.
5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER2 positive AGC treated with H+CT	H+CT	HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.

Primary Outcome Measures

Name	Time	Method
OS	8 years	OS was defined as time from the beginning of first line therapy to death
PFS	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.

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China