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Can a Triple-Drug combo outsmart stubborn stomach cancer?

NCT ID NCT07025889

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial is testing whether combining an experimental drug called IBI343 with an immunotherapy (sintilimab) and standard chemotherapy can help people with a specific type of advanced stomach or gastroesophageal junction cancer. The study focuses on patients whose tumors have a protein called CLDN18.2 and lack HER2, and who have not yet received systemic treatment. The goal is to see if this combination can shrink tumors and improve how long patients live, while monitoring safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IBI343 (an experimental antibody-drug conjugate) combined with sintilimab (an immunotherapy) and chemotherapy (oxaliplatin and S-1)
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with a specific type of advanced gastric cancer, potentially improving tumor shrinkage and survival.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not hold up in larger studies. The combination may also cause significant side effects, including immune-related reactions and chemotherapy toxicity.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures. 2\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited. 3\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC). 4\. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Exclusion Criteria: * 1\. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease. 2\. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study. 3\. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma signet ring cell gastric adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.