FGFR2b positive unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
None listed
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. 2)Diagnosed with unresectable advanced or recurrent disease. 3)Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0?2. 4)Presence of evaluable lesions (measurable lesions are not required). 5)The primary disease meets one of the following conditions: (a)Scheduled for first-line treatment including fluoropyrimidine-based agents. (b)Currently undergoing first-line treatment including fluoropyrimidine-based agents. (c)Determined to be unresponsive (including clinical progression as judged by the attending physician) or intolerant to first-line treatment including fluoropyrimidine-based agents, but has not begun second-line treatment. 6)Submission of preserved tumor tissue samples collected within 2 years prior to obtaining consent (the same date up to 2 years before collection date) or submission of newly collected tumor biopsy specimens is feasible. 7)Adequate explanation of the protocol has been provided to the patient prior to enrollment, and written consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Active double cancer requiring active treatment such as chemotherapy or surgery (synchronous or metachronous double cancer with a disease-free period of 3 years). Exceptions include cases where the risk of metastasis or death is negligible and cure is expected with local treatment (e.g., appropriately treated cervical intraepithelial neoplasia, basal cell carcinoma, cutaneous squamous cell carcinoma, localized prostate cancer treated with curative intent, ductal carcinoma treated in situ with curative intent). 2) History of taxane-based agent administration (including neoadjuvant or adjuvant chemotherapy). 3) History of FGF-FGFR pathway or VEGF-VEGFR pathway inhibitor administration. 4) Cases deemed inappropriate for enrollment by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of FGFR2b-positive cases of unresectable advanced or recurrent gastric cancer | — |
Countries
Japan
Contacts
Public ContactNaoki Ishizuka
West Japan Oncology Group WJOG datacenter
Outcome results
None listed