Can an immunotherapy combo shrink stomach tumors before surgery?

NCT ID NCT03691454

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether adding the immunotherapy drug toripalimab to two different chemotherapy regimens, given before surgery, can help people with locally advanced gastric adenocarcinoma. About 248 adults with HER2-negative stomach cancer will receive either docetaxel, oxaliplatin, and S-1 plus toripalimab, or oxaliplatin and S-1 plus toripalimab. Researchers will compare how often tumors disappear completely after treatment, and track how long patients live without the cancer returning.

What this could mean

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

Active substance
toripalimab combined with chemotherapy (docetaxel, oxaliplatin, and S-1, or oxaliplatin and S-1)
What this could lead to
If it works, this could point toward a more effective pre-surgery treatment for locally advanced gastric cancer, potentially improving long-term survival.
What could go wrong
This is an early-to-mid-stage trial, so the added benefit over standard chemo is unproven. Toripalimab can cause immune-related side effects, and the results may not apply to all patients.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 248 people

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

Started

Jun 2018

Expected to finish

Jun 2027

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 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: 1. Ambulatory males or females with ages ≥ 18. 2. Karnofsky Performance Scale(KPS) ≥ 70. 3. Pathologically confirmed gastric adenocarcinoma (including Lauren classification), with a confirmed HER2-negative status (IHC 0, 1+, or 2+ with FISH negative). 4. A clinical stage of cIII/IVa (AJCC 8th edition gastric cancer TNM staging) diagnosed by enhanced CT/MRI, combined with endoscopic ultrasound (EUS) and diagnostic laparoscopy if necessary. 5. For gastroesophageal junction (GEJ) cancer, only patients with Siewert type III or Siewert type II disease not requiring combined thoracotomy are eligible for enrollment. 6. The tumor can undergo radical resection. 7. The surgeon and the center is experienced and qualified for gastrectomy with D2 lymphadenectomy (the number of lymph nodes examined must at least be 15, so as to ensure the quality of the surgery). 8. Performance status and adequate organ function to tolerate major abdominal surgery. 9. Results of blood routine tests and biochemistry at baseline meet the following standards: hemoglobin (Hb) ≥ 90g/L; absolute neutrophil count (ANC) ≥ 2×10⁹/L; platelet count ≥ 100×10⁹/L; ALT/AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; serum total bilirubin (STB) \< 1×ULN; serum creatinine \< 1×ULN; and serum albumin ≥ 30g/L. 10. Left ventricular ejection fraction (LVEF) ≥ 50% confirmed by echocardiography. 11. Not having any serious concomitant disease that makes the survival less than five years. 12. Be willing to and able to abide by the protocol throughout the study. 13. Having given written informed consent prior to screening and understood that he or she will be free to withdraw from the study at any time without suffering any loss. 14. Agree to provide blood and histological samples. Exclusion Criteria: 1. Pregnancy or lactation women. 2. Women of childbearing potential who are positive for the pregnancy test at the baseline or fail to take the test; women after the menopause must have stopped menstruating for at least 12 months that they will be believed to be unable to get pregnant; 3. Sexually active (potentially fertile) males and females who are unwilling to take any method of contraception during the study; 4. Patients who were previously allergic to monoclonal antibody; 5. Patients with active autoimmune diseases; 6. Patients with any signs of distant metastatic lesions; 7. Patients who previously received cytotoxic chemotherapy, radiotherapy or immunotherapy for the treatment of the present gastric adenocarcinoma, excluding corticosteroids; 8. A medical history of other malignant disease in the last five years, excluding cured skin cancer and carcinoma in situ (CIS); 9. Having uncontrolled epilepsy, central nervous system disease or mental disorder, whether which is clinically serious enough to affect signature of informed consent form or the patient's compliance with oral administration of the study drug will be judged; 10. Having clinically serious (active) heart disease, such as symptomatic coronary heart disease (CHD), NYHA (New York Heart Association) II or more serious congestive heart failure, or serious arrhythmia that requires drug interventions, or a medical history of myocardial infraction (MI) during the last 12 months. 11. Patients who have upper gastrointestinal obstruction, or physiological dysfunction, or malabsorption syndrome, which may affect absorption of S-1. 12. Patients with active infections (such as hepatitis A/B/C and HIV). 13. Patients with severe comorbidity, for instance, uncontrolled diabetes. 14. Patients who concurrently receive potent CYP3A inhibitors. 15. Known to have peripheral neuropathy ≥ NCI CTC AE I; but patients who only present loss of deep tendon reflexes (DTRs) may not be excluded; 16. Patients with history of organ transplantation who require immunosuppressive therapy; 17. Patients who suffer from serious uncontrolled repeated infection, or other serious and uncontrolled disease; 18. Moderate or severe renal dysfunction \[creatinine clearance ≤ 50ml/min (calculated according to the Cockroft-Gault formula, please refer to Appendix 4), or serum creatinine \> the upper limit of normal (ULN); 19. Patients with dihydropyrimidine dehydrogenase (DPD) deficiency; 20. Having received any other study drug or agent / treatment (i.e., participated in other trial) within four weeks prior to randomization). 21. Other patients considered unsuitable for enrollment 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

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

More trials for these conditions

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