Immunotherapy plus chemo shows promise against stomach cancer in early trial
NCT ID NCT06808971
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding the immunotherapy drug adebrelimab to standard chemotherapy can improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer. About 61 participants will receive the drug combination before and after surgery. The main goal is to see how many patients have no cancer cells left in their tumor after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adebrelimab (an immunotherapy drug) combined with nab-paclitaxel, oxaliplatin, and tegafur gimeracil oteracil potassium capsule (chemotherapy drugs)
- What this could lead to
- If this works, it could offer a more effective treatment approach for locally advanced stomach cancer, potentially increasing the chance of no cancer remaining after surgery.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 61 participants, so results may not apply to everyone. The combination of drugs may cause significant side effects, and it's not yet known if it improves long-term survival.
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 61 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2027
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: 1. Patients voluntarily participate in this study and sign informed consent forms; 2. 18-75 years old; 3. Patients whose tumor has been pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and has not received any type of antitumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 4. Confirmed TNM staging by CT or MRI as resectable cT3-4N+M0; 5. ECOG score is 0-1; 6. Patients who are able to swallow pills and capsules normally; 7. Patients whose expected survival period is longer than 12 weeks; 8. The function of important organs meets the following requirements: A. Absolute number of neutrophils (ANC) ≥1.5×10\^9/L B. Platelet number ≥90×10\^9/L; C. Hemoglobin ≥90g/L; D.Total bilirubin ≤1.5×ULN; ALT, AST and/or AKP≤2.5×ULN; E. Serum creatinine ≤1.5×ULN or creatinine clearance rate \>60mL/min (Cockcroft-Gault); F. Activated partial thromboplastin time (APTT) and international standardization ratio (INR) ≤1.5×ULN (for anticoagulation treatments using stable doses such as low-molecular heparin or warfarin and INR can be screened within the expected treatment range of anticoagulants); 9. Female patients with fertility must undergo a blood pregnancy test within 72 hours before the first administration of the drug and the result is negative. During the study period and at least 6 months after the last dose of the study drug, a medically approved contraceptive measure (such as intrauterine birth control device, contraceptive pill or condom) must be used; for men, it should be surgery, sterilization, or agree to use effective contraception during the study period and within 6 months after the last dose of the study drug. Exclusion Criteria: 1. Patients who are known to have peritoneal metastasis or positive peritoneal lavage cytology (CY1P0) or have distant metastasis; 2. Patients whose tumor can not be resected by surgery for tumor reasons or comorbidity or patients who refuse to undergo surgery; 3. Patients who have other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical in situ and breast cancer in situ; 4. The toxicity of previous anti-tumor treatment has not recovered to CTCAE≤grade one (NCI CTCAEv5.0), except for hair loss (any level allowed) and peripheral neuropathy (need to be ≤grade two ); 5. Active bleeding; 6. Patients who had gastrointestinal perforation, abdominal abscess or recent intestinal obstruction or imaging and clinical symptoms with intestinal obstruction in the past 3 months; 7. Uncontrollable hypertension, symptomatic cardiac insufficiency, and severe heart disease within 6 months, including but not limited to: (1) Acute coronary syndrome; (2) Arrhythmias that require drug treatment or have clinical significance, or do not interrupt the use of drugs that may lead to QT prolongation during the research period; (3) Acute myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by the researchers to be unsuitable for participating in this trial. 8\. Patients who have active ulcers, unhealed wounds or fractures; 9. Patients who need antimicrobial treatment in the stage of active infection; 10. Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥500IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number \> normal value upper limit); 11. Patients with congenital or acquired immunodeficiency; 12. Patients who are planning to receive or have previously received organ or allogeneic bone marrow transplantation; 13. At present, patients who are accompanied by interstitial pneumonia or interstitial lung disease, or who have a previous history of interstitial pneumonia or interstitial lung disease that require hormone treatment, or other patients who may interfere with the judgment and treatment of immune-related pulmonary toxicity, fibrosis, organic pneumonia (such as occlusion bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or screening CT showing active pneumonia or severe pulmonary function impairment; active pulmonary tuberculosis; 14. Patients with any active autoimmune diseases or a history of autoimmune diseases with the possibility of recurrence \[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients who can only be controlled by hormone replacement therapy can be included in the group)\]; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, patients with type I diabetes that can be controlled by insulin treatment or have a history of asthma, but who have been completely relieved in childhood and do not require any intervention can be included in the group; asthma patients who need the intervention of bronchodilators cannot be included in the group; 15. Patients who are using immunosuppressive drugs or systemic corticosteroid treatment within 7 days before joining in the group to achieve the purpose of immunosuppression (\>10mg/day of prednisone or other equivalent drugs); 16. Patients who have received live attenuated vaccine within 28 days before joining in the group, or need to inject such vaccines during treatment or within 60 days after the last dose; 17. Oral or intravenous antibiotics or intravenously within 4 weeks before joining the group (except for preventive antibiotics administered intravenously for no more than 48 hours); 18. Known allergies to any study drugs or excipients; 19. Participated in clinical research of other drugs 4 weeks before joining in the group; 20. Lactating women; 21. According to the researcher's judgment, the patient has other factors that may affect the research results or cause the forced termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness that need combined treatment, and serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of patients);
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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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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a vaccine stop GI cancers from returning?
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- Blood test guides immunotherapy for hidden cancer cells