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JRCT ID: jRCTs031240055

Registered date:26/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 26/04/2024
• Target sample size: 140
• Study type: Interventional
• Intervention(s): Collection of tumor samples (before the start of treatment in Part 1 and Part 2)

Outcome(s)

• Primary Outcome: ORR in Part 2
• Secondary Outcome: OS, PFS, TTF in Part 2, safety evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yamaguchi Kensei
• Secondary Sponsor: Sato Kazuto,Daiichi Sankyo Co., Ltd.