Actively Recruiting
Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Led by Jeeyun Lee · Updated on 2025-12-15
50
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric cancer (GC) is the fifth most commonly diagnosed cancer, with over one million cases diagnosed annually worldwide. Human epidermal growth factor receptor 2 (HER2) overexpression in GC (seen in 4.4% to 53.4% of patients in different reports) is predictive biomarker of response to HER2-targeting therapies. Trastuzumab in combination with cisplatin or oxaliplatin, and a fluoropyrimidine (capecitabine or 5-fluorouracil \[5-FU\]), is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction (GEJ) cancer. Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety, efficacy, PK, RO data as well as modeling analysis. The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of ≥ 90% in the majority of participants across a broad spectrum of conditions. This is a phase II study to initially assess the efficacy of perioperative Trastuzumab Deruxtecan (T-DXd) and Capecitabine combination with or without Rilvegostomig in patients with HER2 positive locally advanced unresectable GC and potentially by subsequent protocol amendment in HER2 low locally advanced GC. Other agents may also subsequently be assessed in this protocol, by protocol amendments
CONDITIONS
Official Title
Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must provide fully informed consent before any study procedures.
- Age 19 years or older.
- Body weight greater than 30 kg.
- Pathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with HER2 immunohistochemistry results.
- In the initial group, HER2 positive status (IHC 3+ or IHC 2+/ISH positive).
- Locally advanced unresectable disease as determined by a physician, with no distant organ metastasis.
- ECOG performance status of 0 or 1 without worsening between screening and first treatment dose.
- Left ventricular ejection fraction of 50% or higher by echocardiogram or MUGA scan within 28 days before treatment.
- Measurable target disease according to RECIST version 1.1.
- Adequate organ, bone marrow, liver, and kidney function within 14 days before treatment, with specific blood count and chemistry requirements.
- Female patients must use highly effective contraception during the trial and for 7 months after stopping treatment, or be not of childbearing potential.
- Non-sterilized male patients sexually active with female partners of childbearing potential must use condoms with spermicide during the study and for 4 months after the last dose.
- Male patients should avoid fathering a child or sperm donation during the study and for 4 months after the last dose; sperm preservation is recommended before enrollment.
You will not qualify if you...
- Evidence of peritoneal metastasis or distant metastasis.
- Known deficiency of the DPD enzyme.
- Uncontrolled illness including active infection, uncontrolled high blood pressure, serious gastrointestinal conditions with diarrhea, or psychiatric/social issues limiting study compliance.
- Unresolved toxicities of grade 2 or higher from prior therapy, except certain controlled conditions.
- History of organ transplant.
- Active primary immunodeficiency or active infectious diseases; active or recent autoimmune or inflammatory disorders requiring immunosuppressive treatment.
- History or current signs of interstitial lung disease or pneumonitis.
- Active hepatitis B or C infection, or poorly controlled HIV infection.
- Certain heart conditions including abnormal ECG findings, uncontrolled blood pressure, heart failure, recent heart attack, or severe valvular disease.
- Pregnant or breastfeeding females or patients unwilling to use effective contraception.
- Known allergy or hypersensitivity to study drugs or their components.
- Recent use of immunosuppressive medications, with some exceptions.
- For patients receiving Rilvegostomig: serious chronic gastrointestinal conditions with diarrhea, active skin diseases requiring systemic treatment, or autoimmune disorders needing chronic immunosuppressive therapy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Jeeyun Lee, Ph, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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