Can an immunotherapy combo shrink stomach tumors before surgery?
NCT ID NCT04354662
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
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May 2020
- Finished
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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
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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 Hide 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.
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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
-
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
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Other studies related to the condition(s) this trial covers.
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