Using a prospective, exploratory trial design, we aim to evaluate the efficacy and safety of RC-Trastuzumab combined with Rilafup Alpha in treating first-line systemically treated HER2（Human Epidermal Growth Factor Receptor 2 ） medium-to-high expressing gastric/gastroesophageal junction adenocarcinoma that has failed standard therapy. Participants, after being fully informed and signing the consent form, and passing the screening, enter the treatment phase. The trial medications include RC-Trastuzumab and Rilafup Alpha: RC-Trastuzumab: 4.8 mg/kg i.v.gtt on day 1, every 3 weeks; continue until disease progression, intolerance, or study withdrawal. Rilafup Alpha: 1800 mg or 30 mg/kg i.v.gtt on day 1, every 3 weeks; continue until disease progression, intolerance, or study withdrawal, with a maximum treatment duration of 2 years.
Efficacy assessment: Imaging is done every 2 cycles from the start of therapy until the end of treatment, consent withdrawal, or death. If participants leave the study for any reason and no imaging has been done within 4 weeks before stopping treatment, imaging should be performed at exit. Participants with CR or PR are to have a repeat imaging evaluation 4 weeks later for confirmation. According to RECIST(Response Evaluation Criteria in Solid Tumors version ) 1.1 criteria, for those showing initial PD but clinically stable, confirmation should be done after a 4-week interval, and imaging resumes at the next scheduled time point.
Additionally, the study evaluates drug safety and survival. Safety assessment: Adverse events are graded according to NCI-CTCAE(National Cancer Institute Common Terminology Criteria for Adverse Events) 6.0. During the trial, adverse events should be recorded accurately, including onset, severity, relation to study drugs, duration, actions taken, and outcome. Survival assessment: The follow-up period starts after the last dose of study drug. The study center conducts follow-ups every 3 months during the first year after treatment, then every 6 months, until death or study completion. Follow-ups by phone are acceptable.
Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation with follow-up;
Age ≥18 years;
Eastern Cooperative Oncology Group（ECOG） score 0-1;
Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant metastasis;
Known allergy to any investigational drug or its excipients, or allergy to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.).
(1) Received any investigational drug within 4 weeks before the first use of the study drug; (2) subjects who require systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressants within 2 weeks before the first use of the study drug, except for using corticosteroids for local esophageal inflammation, allergy prevention, or nausea and vomiting; (3) other special situations need to be discussed with the sponsor. In the absence of active autoimmune disease, inhaled or local steroids and adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are allowed; (4) subjects who have received anti-cancer vaccines or live vaccines within 4 weeks before the first administration of the study drug.
Having any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism), except for vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood; autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone and type 1 diabetes patients using a stable dose of insulin can be included.
History of immunodeficiency, including positive HIV test, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant or allogeneic bone marrow transplantation.
Single group
Trastuzumab Rezetecan+Retlirafusp alfa
DrugTrastuzumab Rezetecan: 4.8 mg/kg i.v.gtt. on day 1, every 3 weeks; use until disease progression, intolerance, or withdrawal from the study. Retlirafusp alfa: 1800 mg or 30 mg/kg i.v.gtt. on day 1, every 3 weeks; use until disease progression, intolerance, or withdrawal from the study, with a maximum treatment duration of 2 years.
Objective response rate
disease control rate
Progression-free survival
Duration of relief
Overall survival
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