Clinical trial · Observational
Trastuzumab Based Therapy in HER2 Positive AGC
Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study
NCT03024450CI-TRIAL-00025590completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| H+CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2 positive AGC treated with H+CT
- description
- 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.
- interventionNames
- Drug: H+CT
Primary outcomes (2)
- measure
- OS
- timeFrame
- 8 years
- description
- OS was defined as time from the beginning of first line therapy to death
- measure
- PFS
- timeFrame
- 8 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- RESULTBang 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, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. PMID 20728210
- RESULTHalon 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. Epub 2012 May 3. PMID 22645475
- RESULTShitara 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. Epub 2012 Jul 14. PMID 22797858
- RESULTGomez-Martin C, Lopez-Rios F, Aparicio J, Barriuso J, Garcia-Carbonero R, Pazo R, Rivera F, Salgado M, Salud A, Vazquez-Sequeiros E, Lordick F. A critical review of HER2-positive gastric cancer evaluation and treatment: from trastuzumab, and beyond. Cancer Lett. 2014 Aug 28;351(1):30-40. doi: 10.1016/j.canlet.2014.05.019. Epub 2014 Jun 3. PMID 24943493
- RESULTGong 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 multicenter, phase II trial. BMC Cancer. 2016 Feb 8;16:68. doi: 10.1186/s12885-016-2092-9. PMID 26857702
- RESULTJiang 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. 2017 Feb;19(2):197-203. doi: 10.1007/s12094-016-1523-z. Epub 2016 Jun 20.