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New drug combo aims to outperform immunotherapy in Hard-to-Treat stomach cancer

NCT ID NCT07716449

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether an experimental drug called QLS31905, combined with chemotherapy (CAPOX), works better than the current immunotherapy drug sintilimab plus the same chemotherapy for people with advanced gastric or gastroesophageal junction cancer. The study includes patients whose tumors have a specific protein (CLDN18.2) and low PD-L1 levels, a group that often does not benefit from standard immunotherapy. Researchers will measure how long participants live without their cancer worsening.

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 an experimental drug called QLS31905 and chemotherapy (CAPOX: capecitabine and oxaliplatin)
What this could lead to
If successful, this could provide a new first-line treatment option for people with a specific type of advanced gastric cancer that does not respond well to current immunotherapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The experimental combination may not prove more effective or safer than the existing treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 560 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 years and older

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: * Subjects voluntarily participate in the study and sign the informed consent form; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; * Expected survival time ≥ 12 weeks; * Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma; * No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease; * At least one measurable lesion per RECIST v1.1; * Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria: * Known history of allergy to any component of the study drug; * Other second primary malignant neoplasm within 5 years; * Significant cardiovascular and cerebrovascular disorders within 6 months before randomization; * Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation; * Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc; * Previous treatment targeting CLDN18.2; * Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Gastric or gastroesophageal junction adenocarcinoma

How to take part

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

  1. 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 ↗

  2. 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.

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