Trastuzumab Based Therapy in HER2 Positive AGC

Gastric Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024450
• Other study ID #: ZS-ON-08
• Status: Completed
• Phase: N/A
• First received: January 2, 2017
• Last updated: January 21, 2017
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• H+CT
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.

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Aizawa M, Nagatsuma AK, Kitada K, Kuwata T, Fujii S, Kinoshita T, Ochiai A. Evaluation of HER2-based biology in 1,006 cases of gastric cancer in a Japanese population. Gastric Cancer. 2014 Jan;17(1):34-42. doi: 10.1007/s10120-013-0239-9. — View Citation

Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators.. Trastuzumab in combination with chemotherapy versus chemotherapy — View Citation

Gomez-Martín C, Lopez-Rios F, Aparicio J, Barriuso J, García-Carbonero R, Pazo R, Rivera F, Salgado M, Salud A, Vázquez-Sequeiros E, Lordick F. A critical review of HER2-positive gastric cancer evaluation and treatment: from trastuzumab, and beyond. Cance — View Citation

Gong J, Liu T, Fan Q, Bai L, Bi F, Qin S, Wang J, Xu N, Cheng Y, Bai Y, Liu W, Wang L, Shen L. Optimal regimen of trastuzumab in combination with oxaliplatin/ capecitabine in first-line treatment of HER2-positive advanced gastric cancer (CGOG1001): a mult — View Citation

Halon A, Donizy P, Biecek P, Rudno-Rudzinska J, Kielan W, Matkowski R. HER-2 expression in immunohistochemistry has no prognostic significance in gastric cancer patients. ScientificWorldJournal. 2012;2012:941259. doi: 10.1100/2012/941259. — View Citation

Jiang H, Li Q, Yu S, Yu Y, Wang Y, Li W, Cui Y, Liu T. Impact of HER2 expression on outcome in gastric cancer patients with liver metastasis. Clin Transl Oncol. 2016 Jun 20. [Epub ahead of print] — View Citation

Shitara K, Yatabe Y, Matsuo K, Sugano M, Kondo C, Takahari D, Ura T, Tajika M, Ito S, Muro K. Prognosis of patients with advanced gastric cancer by HER2 status and trastuzumab treatment. Gastric Cancer. 2013 Apr;16(2):261-7. doi: 10.1007/s10120-012-0179-9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	OS was defined as time from the beginning of first line therapy to death	8 years
Primary	PFS	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.	8 years