New drug combo aims to wipe out stomach cancer before surgery
NCT ID NCT07483567
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a new drug called IBI343 to standard immunotherapy and chemotherapy can help eliminate stomach cancer more effectively before and after surgery. It involves 90 adults with a specific type of stomach cancer that has not spread widely. Participants will receive the drug combination either before and after surgery, and researchers will check how many have no cancer left 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
- IBI343 (a drug targeting CLDN18.2) combined with sintilimab (an immunotherapy) and chemotherapy (oxaliplatin and S-1)
- What this could lead to
- If successful, this combination could improve the chance of eliminating all cancer before and after surgery for people with a specific type of gastric cancer.
- What could go wrong
- This is an early phase 2 trial with only 90 participants, so results may not apply to everyone. The combination may cause significant side effects, and it is not yet known if it will improve 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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Jun 2031
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol. 2. Male or female, 18 years ≤ age ≤ 75 years; 3. ECOG score 0-1; 4. Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II/III type participants are allowed for gastroesophageal junction cancer; 5. Clinical staging based on enhanced CT/MRI examination, clinical stage T3\~4a with positive lymph nodes, and no distant metastasis; 6. The research center and surgeon can perform radical D2 lymph node dissection surgery, R0 resection; 7. Physical condition and organ function allow for major abdominal surgery; 8. Confirmed CLDN18.2 expression by central laboratory pathological tissue testing. 9. Adequate organ and bone marrow function. 10. Echocardiography confirms left ventricular ejection fraction (LVEF) ≥ 50%; 11. Female participants must agree not to breastfeed from screening through the entire treatment period and up to 6 months after the last dose. 12. Female participants of childbearing potential or male participants whose partners are of childbearing potential must use effective contraception from screening through the entire treatment period and up to 9 months after the last dose. Exclusion criteria 1. HER2 positive. 2. Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study. 3. Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication. 4. Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug. 5. Received any live vaccine within 4 weeks prior to the first dose of the study drug or plans to receive any during the study period. 6. Underwent major surgery (craniotomy, thoracotomy, laparotomy, laparoscopic resection of significant tissues or organs, or other as defined by the investigator, excluding needle biopsies) within 4 weeks prior to the first dose of the study drug, or has unhealed wounds, ulcers, or fractures. 7. Patients who received steroids (\>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before enrollment. However, patients are allowed to enroll if they use topical or inhaled steroids, or adrenal replacement therapy with ≤10 mg/day prednisone equivalent, without active autoimmune disease. 8. History of interstitial lung disease, non-infectious pneumonia, severely impaired pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having such conditions during the screening period. 9. Presence of uncontrolled diseases, such as: • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg). 10. Any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, etc. 11. History of deep vein thrombosis (patients stable on anticoagulation for at least 2 weeks can be enrolled), pulmonary embolism, or any other serious venous thromboembolic event within 3 months prior to the first dose of the study drug (implantable venous port or catheter-related thrombosis, or superficial venous thrombosis, are not considered "serious" venous thromboembolic events). 12. Any life-threatening bleeding event or Grade 3 or 4 gastrointestinal/variceal bleeding event requiring transfusion, endoscopic, or surgical intervention within 3 months prior to the first dose of the study drug. 13. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh B or more severe liver cirrhosis. 14. Complete or partial intestinal obstruction present during the screening period or history of complete or partial intestinal obstruction within 3 months prior to the first dose of the study drug, or risk of bowel perforation (including but not limited to acute diverticulitis, history of intra-abdominal abscess) or history of inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 15. Other acute or chronic diseases or laboratory abnormalities that may result in: increased risk related to participation in the study or administration of the study drug, interference with the interpretation of study results, and participants deemed ineligible for the study by the investigator. 16. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer (such as leukemoid reaction, etc.), which may lead to higher medical risks and/or uncertainty in survival evaluation. 17. Neurological, psychiatric, or social conditions that: affect compliance with study requirements, significantly increase the risk of adverse events, or impair the ability of the participant to provide written informed consent. 18. History of other primary malignant tumors. 19. Known history of immunodeficiency. 20. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 21. History of allergic reactions to the drugs used in this study. 22. Other conditions deemed unsuitable for participation in this study by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CLDN18.2 positive are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a new drug shrink advanced solid tumors?
- Can adding immunotherapy to standard cancer care be safe for indian patients?
- Can a targeted drug duo boost the power of surgery for stomach cancer?
- Blood test may spot hidden stomach cancer recurrence risk