Clinical trial NCT03024450: Trastuzumab Based Therapy in HER2 Positive AGC
Official title: Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Adenocarcinoma
Keywords: Gastric cancer
HER2
trastuzumab
prognosis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with HER2 positive advanced or metastatic gastric adenocarcinoma in Shanghai Zhongshan Hospital, Fu Dan University were prospectively collected. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: 8 years
measure: PFS
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Tianshu / Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
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