gastric cancer
Conditions
Interventions
Collection of tumor samples (before the start of treatment in Part 1 and Part 2)
Sponsors
Yamaguchi Kensei
Sato Kazuto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1 1)Patients who have given their written consent to participate in the study 2)Age>=18 years at the time of informed consent 3)Histopathologically diagnosed before first line chemotherapy as HER2-positive (IHC3+ or IHC2+/ISH+) gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) 4)ECOG PS 0-2 5)Patients who experienced progression, on and, after treatment with trastuzumab containing regimens in first line treatment 6)(Patients who submit tumor tissues only) Patients who can provide a sufficient volume of tumor specimen for HER2 status (IHC/ISH) confirmation and written consent for the tumor specimen submission Part 2 1)Patients who have given their written consent to participate in the study 2)ECOG PS 0-2 3)Patients who participated in Part 1 of this study and were refractory or intolerant to treatment at second line 4)Patinets who planned to receive T-DXd at third line according to electronic package insert 5)At the enrollment in Part 2, patients who were considered to have measurable target lesion based on RECIST ver. 1.1 by the investigator or who have no measurable target lesion confirmed , such as those experienced disappearance of measurable target lesion during the Part 1. 6)(Patients who submit tumor tissues only) Patients who can provide a sufficient volume of tumor specimen for HER2 status (IHC/ISH) confirmation and written consent for the tumor specimen submission
Exclusion criteria
Exclusion criteria: Part 1 1) Patients with a previous complications or medical history of interstitial lung disease 2) Patients who have advanced multiple primary malignancies which are considered to affect the evaluation of T-DXd by investigator 3) Patients with a treatment history of T-DXd 4) Patients who received anticancer therapy after treatment with trastuzumab containing regimen in first line 5) Patients who scheduled to receive trastuzumab as second line treatment 6) Patients who were considered ineligible for this study by investigator. Part 2 1) Patients with a previous complications or medical history of interstitial lung disease 2) Patients who have advanced multiple primary malignancies which are considered to affect the evaluation of T-DXd by investigator 3) Patients who received anticancer therapy after treatment in Part 1 of this study 4) Patients who were considered ineligible for this study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR in Part 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, PFS, TTF in Part 2, safety evaluation | — |
Contacts
Public ContactKensei Yamaguchi
Cancer Institute Hospital
Outcome results
None listed