Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can an immunotherapy combo shrink stomach tumors before surgery?

NCT ID NCT04354662

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether adding the immunotherapy drug toripalimab to a standard chemotherapy regimen (FLOT) before surgery can improve outcomes for people with locally advanced gastric cancer. Participants receive four cycles of the combination, then undergo surgery, and are followed for several years. The study aims to see if this approach increases the rate of complete tumor disappearance and improves long-term survival.

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 FLOT chemotherapy (docetaxel, oxaliplatin, leucovorin, fluorouracil)
What this could lead to
If successful, this combination could improve the chance of eliminating the tumor before surgery and extend survival for people with gastric cancer.
What could go wrong
This is a small phase 2 trial, so results may not be conclusive. Adding immunotherapy to chemotherapy can increase side effects, and not all patients may benefit.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

51 people

The number who actually took part.

Started

May 2020

Finished

Jul 2026

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. locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the gastric or gastroesophageal junction without distant metastases (M0) 2. no previous surgical resection 3. no previous cytostatic chemotherapy 4. Age \> 18 years, no more than 75 years (female and male) 5. Karnofsky Performance Status score of physical condition is 80-100 6. surgical resectability 7. Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy 8. Leucocytes \> 4.000/µl 9. Platelets \> 100.000/µl 10. Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min 11. written informed consent. Exclusion Criteria: 1. Distant metastasis or local invasion of adjacent organs; 2. Recurrent or residual gastric cancer; 3. Having or having had autoimmune disease; 4. Previous organ transplantation or HIV patients; 5. Allergy or contraindications to Toripalimab, 5- Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel; 6. Malignant secondary disease; 7. Severe non-surgical disease or acute infection; 8. Peripheral polyneuropathy \> NCI grad I; 9. Blood system, liver and kidney function were damaged; 10. Symptomatic brain metastasis; 11. Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency and severe gravity valve disease; 12. Psychotic subjects who are not easy to control; 13. Pregnant or lactating subjects.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gastric cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

More trials for these conditions

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