New drug combo targets Hard-to-Treat stomach cancer in early trial
NCT ID NCT07325630
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding the drug IBI363 to standard chemotherapy can improve outcomes for people with a specific type of locally advanced stomach or gastroesophageal junction cancer (MHC-II-negative). The study will enroll 60 participants who will receive the combination before and after surgery. The main goal is to see how many patients have no cancer cells left in their surgical samples.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI363 combined with chemotherapy (oxaliplatin and capecitabine or S-1)
- What this could lead to
- If successful, this could lead to a more effective treatment regimen for a specific type of gastric cancer, potentially increasing the chance of complete tumor removal before surgery.
- What could go wrong
- This is an early-phase, single-center trial with only 60 participants, so results may not apply broadly. The combination therapy may cause significant side effects, and the benefit over standard chemotherapy alone is not yet proven.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 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.
Key Inclusion Criteria: 1. Patients voluntarily enrolled in this study and signed informed consent forms; 2. Age 18-75 years; 3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. MHC-II negative, with \<5% tumour cells displaying staining \<2+ (grade 2 or stronger); 5. Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and/or laparoscopy (per AJCC 8th Edition staging); 6. No prior antineoplastic therapy for current disease (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy); 7. Scheduled for surgical intervention following completion of neoadjuvant therapy; 8. Able to swallow tablets orally; 9. ECOG performance status 0-1; 10. Expected survival ≥6 months. Key Exclusion Criteria: 1. Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational medicinal product. 2. Known signs of active bleeding from a lesion. 3. Patients with known dMMR/MSI-H status. 4. Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets. 5. Subjects with unresolved Grade \>1 toxicity related to any prior antineoplastic therapy (excluding persistent Grade 2 alopecia, anaemia, peripheral neuropathy, electrolyte abnormalities correctable with treatment, or endocrine abnormalities controlled and stable with hormone replacement therapy). 6. Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis). 7. Known hypersensitivity to any monoclonal antibody or component of the chemotherapy agents (capecitabine, oxaliplatin) (resulting in Grade 3 or higher hypersensitivity reaction). 8. History of epileptic seizures, active, newly diagnosed, or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases. 9. Clinically significant cardiovascular or cerebrovascular disease.
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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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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dual immunotherapy plus chemo before surgery: a new way to shrink stomach tumors?
- Can immunotherapy wipe out stomach cancer before surgery?
- Arterial chemo combo shows promise in stomach cancer trial
- New drug cocktail aims to fight Hard-to-Treat stomach cancers
- New triple therapy aims to shrink stomach tumors before surgery
- Immunotherapy duo aims to shrink stomach tumors before surgery