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AzTrials

Locally Advanced Gastric or Gastroesophageal Junction CancerPhase 3NCT07522151

Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer

A Phase 3 study testing Adebrelimab plus S-1 and oxaliplatin and Adebrelimab blank preparation plus S-1 and oxaliplatin. in people with Locally Advanced Gastric or Gastroesophageal Junction Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Adebrelimab plus S-1 and oxaliplatin and Adebrelimab blank preparation plus S-1 and oxaliplatin.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
874 participants
Where
1 siteChina
Study dates
7 May 2026to Feb 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer.
  • Age: ≥18 years old, <75 years old, both male and female are eligible.
  • Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy + radical surgery for curative purposes.
  • Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria.
  • Fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections obtained within 6 months before randomization can be provided.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1.
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  • Expected survival ≥ 6 months.
  • Adequate organ and bone marrow function.
  • Female subjects are either infertile or fertile, with a negative serum pregnancy test result within 3 days before the start of study medication and not in the lactation period. Fertile female subjects and male subjects whose partners are fertile must agree to avoid sperm/egg donation from the time of signing the informed consent form until 6 months after the last administration of the investigational drug, and comply with relevant contraceptive requirements.
  • Consent has been obtained from the individual and the informed consent form has been signed, willing and able to comply with planned visits, study treatment, laboratory tests, and other trial procedures.

Who cannot join

  • Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other histological types.
  • Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for clinical staging assessment using the 8th edition of the AJCC gastric cancer staging criteria, or not suitable for conventional surgical methods or approaches for gastric cancer.
  • The subject's weight has decreased by more than 20% within 2 months before randomization.
  • Previous anti-tumor treatment for gastric cancer/gastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization).
  • Known allergy to any component of the investigational drug (including adibelimab/placebo, tegafur, and oxaliplatin), or allergy to humanized monoclonal antibody products.
  • Diagnosis of any other malignant tumor within 5 years before entering the study, except for locally treatable and cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
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  • History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or organ transplantation (including allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, etc.); history of active autoimmune disease, except for immune disorders that do not require systemic treatment (such as vitiligo, psoriasis, etc.) or autoimmune diseases that can be improved through hormone replacement therapy (such as type 1 diabetes or hypothyroidism).
  • Severe, unhealed or open wounds, active ulcers, or untreated fractures.
  • Active severe digestive system diseases.
  • Presence of interstitial pneumonia or interstitial lung disease.
  • Severe cardiovascular or metabolic diseases.
  • Active HBV or HCV infection (HBsAg positive and viral copy number ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the upper limit of normal at the research center), or co-infection with hepatitis B and hepatitis C.
  • Active tuberculosis infection within 1 year before randomization (including but not limited to pulmonary tuberculosis, intestinal tuberculosis, etc.), or a history of active tuberculosis infection more than 1 year ago but without regular treatment.
  • Severe infection within 4 weeks before randomization.
  • Known history of abuse of psychotropic drugs or drug addiction.
  • Presence of other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participation in the study, or interfere with the study results, and patients considered unsuitable for participation in the study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bin Bai contact

+0518-81220121

bin.bai@hengrui.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 10000

    Jiafu Ji

    Lin Shen

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter Phase III Trial of Adebrelimab (SHR-1316) Plus S-1 and Oxaliplatin (SOX) Versus Placebo Plus S-1 and Oxaliplatin in the Perioperative Treatment of Resectable Gastric or Gastroesophageal Junction Cancer

This study was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens.

Being tested
Adebrelimab plus S-1 and oxaliplatin, Adebrelimab blank preparation plus S-1 and oxaliplatin.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adebrelimab plus S-1 and oxaliplatinDrug

    Adebrelimab plus S-1 and oxaliplatin

  • Adebrelimab blank preparation plus S-1 and oxaliplatin.Drug

    Adebrelimab blank preparation plus S-1 and oxaliplatin.

Study groups in NCT07522151
Study groupRoleWhat they receive
Treatment group A: Adebrelimab with SOX.ExperimentalNot described
Receives: Drug: Adebrelimab plus S-1 and oxaliplatin
Treatment group B: placebo with SOX.ExperimentalNot described
Receives: Drug: Adebrelimab blank preparation plus S-1 and oxaliplatin.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed EFS

    Assessments BY INVESTIGATORS

    Measured: About 8 years

Secondary outcomes (10)

  1. Complete response (pCR) rate as assessed by the Pathology Review Committee (PRC)

    Complete remission (pCR) rates after surgery

    Measured: About 3 years

  2. Rate of pathologically significant response (MPR) as assessed by the Pathology Review Committee (PRC)

    Pathologically significant response (MPR) rate after surgery

    Measured: About 3 years

  3. EFS as assessed by an independent review committee (IRC)

    Independent Review Committee (IRC) evaluation

    Measured: About 8 years

  4. DFS, as assessed by investigator /IRC

    Investigator /IRC assessment

    Measured: About 8 years

  5. pCR rate by central pathological evaluation

    Central pathological evaluation was studied

    Measured: About 3 years

  6. R0 resection rate of neoadjuvant therapy evaluated by investigators in different treatment groups

    Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator

    Measured: About 8 years

  7. D2 radical resection rate of neoadjuvant therapy evaluated by investigators in different treatment groups

    Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator

    Measured: About 8 years

  8. objective response rate (ORR) of neoadjuvant therapy evaluated by investigators in different treatment groups

    Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator

    Measured: About 8 years

  9. The incidence of adverse events (AE) were evaluated according to NCI-CTCAE 6.0

    NCI-CTCAE 6.0 was used for evaluation

    Measured: About 4 years

  10. The severity of serious adverse events (SAE) were evaluated according to NCI-CTCAE 6.0

    NCI-CTCAE 6.0 was used for evaluation

    Measured: About 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start7 May 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionFeb 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
874 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07522151
Sponsor's protocol ID
SHR-1316-309
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
13 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adebrelimab plus S-1 and oxaliplatin and Adebrelimab blank preparation plus S-1 and oxaliplatin. in people with Locally Advanced Gastric or Gastroesophageal Junction Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bin Bai (+0518-81220121, bin.bai@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed EFS (time frame: About 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07522151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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