Triple-Drug cocktail aims to wipe out stomach tumors before surgery
NCT ID NCT07716111
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This phase II trial tests whether adding an immunotherapy drug (retlirafusp alfa) and possibly a third drug (pertuzumab) to the targeted therapy trastuzumab rezetecan can completely eliminate tumors before surgery in people with locally advanced HER2-positive stomach or gastroesophageal junction cancer. Participants receive four cycles of the drug combination over about 12 weeks, then undergo surgery to remove any remaining cancer. The main goal is to see how many patients have no cancer cells left in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of trastuzumab rezetecan, retlirafusp alfa, and optionally pertuzumab
- What this could lead to
- If successful, this approach could shrink tumors before surgery, potentially improving surgical outcomes and long-term survival for people with HER2-positive gastric cancer.
- What could go wrong
- This is a small, early-phase study with only 24 participants, so results may not apply broadly. The combination therapy may also cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary Participation: The subject voluntarily agrees to participate in this study, is able to sign the informed consent form (ICF), and has good compliance. * Age and Gender: Aged 18 to 75 years (at the time of signing the ICF), regardless of gender. * Diagnosis and Staging: Histologically and/or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. Diagnosed as locally advanced according to the AJCC 8th Edition criteria, with cTNM staged as T3-4N+M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI scans (combined with diagnostic laparoscopy if necessary). The subject must agree to undergo radical surgery, and the investigator assesses the lesion as potentially resectable. * Treatment History: No prior systemic therapy for the current disease, including anti-tumor radiotherapy, chemotherapy, or immunotherapy. * HER2 Status: Confirmed HER2 IHC 3+ or HER2 IHC 2+ with positive FISH result based on endoscopic biopsy tissue IHC results. * Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H; at least one of the three criteria must be met. * Performance Status: ECOG score of 0-1. * Life Expectancy: Estimated life expectancy ≥6 months. * Organ Function: Adequate major organ function * Contraception and Pregnancy: Subjects of childbearing potential must use appropriate contraception methods during the study and for 120 days after the end of the study. Serum pregnancy test must be negative within 7 days prior to study enrollment, and the subject must not be breastfeeding. Exclusion Criteria: * Other Malignancies: Concomitant malignant diseases other than gastric cancer (excluding early-stage tumors that have been radically cured). * Bleeding Risk: Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months prior to signing the ICF, or judged by the investigator to be at risk of massive gastrointestinal bleeding) or have received blood transfusion therapy within 4 weeks prior to the administration of the study drug. * Concurrent Studies: Currently participating in other interventional drug clinical studies, or have received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose. * Prior Therapies: Previous exposure to the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 agents, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.). * Autoimmune Disease: Active autoimmune disease that required systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Note: The use of physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment. * Prior Medication: Received systemic treatment with Traditional Chinese Medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukins, excluding local use for pleural effusion control) within 2 weeks prior to the first dose. * Transplant History: Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation. * Allergy: Known hypersensitivity to the drugs used in this study. * Neuropathy: Peripheral neuropathy ≥ Grade 2. * HIV Infection: Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV 1/2 antibody positive). * Hepatitis: Subjects with active Hepatitis B or Hepatitis C. * Vaccination: Received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1). Note: Inactivated virus vaccines for seasonal influenza (injection) are permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines administered intranasally are not permitted. * Pregnancy/Lactation: Pregnant or breastfeeding women. * Uncontrolled Systemic Disease: Presence of any severe or uncontrolled systemic disease. * Patients with mental disorders who are unable to cooperate with treatment; * Other: Any history or evidence of disease, treatment, or abnormal laboratory values that may interfere with trial results or hinder the subject's full participation in the study, or other conditions deemed by the investigator to pose potential risks or make the subject unsuitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, 210000, China
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- New drug cocktail aims to shrink stomach tumors before surgery