Gastric Cancer
Conditions
Interventions
None listed
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The cancer is pathologically confirmed (via resected surgical specimens or biopsied tissue) to be gastric cancer (adenocarcinoma). 2. The patient has advanced/recurrent gastric cancer not amenable to curative surgery. 3. The primary tumor or a metastatic focus was determined to be HER2-Positive before trastuzumab treatment. Positivity for HER2:3+ on an IKC test,or 2+ on an IHC test and positive on a FISH test (If the result of the IHC test is 2+,the result of the FISH test must be positive,i.e.presence of HER2 gene amplification). 4. The cancer is radiologically or clinically diagnosed as progressive disease against trastuzumab treatment at least once by the investigators. Trastuzumab should be administered at least twice as scheduled. The cancer is pathologically confirmed (via resected surgical specimens or biopsied tissue) to be adenocarcinoma within 3 months after the end of trastuzumab treatment without receiving any other antitumor agents.
Exclusion criteria
Exclusion criteria: Patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of HER2 positivity after resistance to trastuzumab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Amplification of EGFR and c-met gene, PIK3CA gene mutation as biomarkers that associate with resistance to trastuzumab. | — |
Countries
Japan
Contacts
Public ContactKSCC Research Secretariat
Clinical Research Support Center Kyushu KSCC Research Secretariat
Outcome results
None listed