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Immunotherapy combo shows promise in stomach cancer trial

NCT ID NCT05008783

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether adding an immunotherapy drug called AK104 to standard chemotherapy helps people with advanced stomach or gastroesophageal junction cancer live longer. About 610 participants received either AK104 plus chemo or a placebo plus chemo. The study is complete, and researchers are looking at overall survival and tumor response.

What this could mean

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

Active substance
AK104 (a type of immunotherapy) plus oxaliplatin and capecitabine (chemotherapy)
What this could lead to
If it works, this could offer a new first-line treatment option for people with advanced stomach or gastroesophageal junction cancer, potentially improving survival.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. The added immunotherapy may cause immune-related side effects, and it may not improve survival compared to chemotherapy alone.

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

610 people

The number who actually took part.

Started

Sep 2021

Finished

Aug 2025

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

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

Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be enrolled in the study: 1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. 3. Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma. 4. Unresectable locally advanced or metastatic gastric adenocarcinoma or GEJ adenocarcinoma. 5. Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months. 6. Subjects have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion. Exclusion Criteria: * Subjects who meet any of the following criteria are not eligible to participate in this study: 1. Subjects with known HER2-positive gastric or GEJ adenocarcinoma. 2. Histopathology or cytology confirmed other pathological types, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma. 3. Subjects who received palliative local therapy for non-target lesions within 2 weeks prior to the first dose; systemic nonspecific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc.) within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose. 4. Subjects who received any prior treatments targeting the mechanism of tumor immunity. 5. Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose. If the perforation or fistula has been treated with resection or repair and the disease has recovered or resolved as judged by the Investigator, enrollment may be allowed. 6. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). 7. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of cervix, carcinoma in situ of breast, localized prostate cancer, etc. 8. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease. 9. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month). 10. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.

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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.

Contacts and locations

Locations

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100143, China

  • The First Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang, 310003, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 20032, China

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