Tokyo, Sept. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062312) titled 'A Multicenter Prospective Observational Study Evaluating Effectiveness and Safety of Trastuzumab Deruxtecan in HER2-Positive Gastric Cancer Patients without HER2 Status Immediately Prior to Second-Line Treatment' on Sept. 21.

Study Type: Observational

Primary Sponsor: Institute - NAGOYA UNIVERSITY HOSPITAL

Condition: Condition - HER2-positive gastric cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effectiveness and safety of T-DXd as second-line treatment in real-world patients with initially HER2-positive gastric cancer whose HER2 status has not been reassessed immediately prior to second-line treatment initiation. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients with unresectable advanced or recurrent gastric cancer (gastric adenocarcinoma or gastroesophageal junction adenocarcinoma) that has progressed after prior chemotherapy 2) Patients diagnosed with HER2-positive gastric cancer prior to first-line therapy based on pathological assessment (IHC 3+ or IHC 2+ and ISH-positive) 3) Patients with a history of receiving first-line chemotherapy including trastuzumab 4) Patients planned to receive T-DXd as second-line therapy 5) Patients who have not undergone HER2 IHC testing between the initiation of trastuzumab in first-line therapy and the initiation of T-DXd in second-line therapy, or patients whose IHC test results were uninterpretable 6) Patients with measurable lesions 7) Patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 8) Patients who have provided written informed consent Key exclusion criteria - 1) Patients with a history of hypersensitivity to T-DXd or its components 2) Patients with prior treatment with T-DXd 3) Patients with active multiple primary cancers that are considered by the investigator to potentially affect the evaluation of T-DXd 4) Patients with a history of perioperative treatment who initiated trastuzumab-containing chemotherapy within 6 months after the completion of the perioperative Treatment 5) Patients deemed ineligible for this study by the investigator Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 22 Day Date of IRB - 2026 Year 07 Month 22 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071303

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