Promising cocktail may turn inoperable stomach cancer into surgical candidates
NCT ID NCT05177068
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests a combination of three drugs—fruquintinib, sintilimab, and SOX (S-1 plus oxaliplatin)—as a pre-surgery treatment for people with stage IV gastric cancer that cannot be fully removed. The goal is to shrink the tumor enough to allow complete surgical removal. The study includes 42 participants and measures how many achieve successful surgery and how the cancer responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fruquintinib, sintilimab, S-1, and oxaliplatin
- What this could lead to
- If successful, this combination could help more patients with advanced gastric cancer become eligible for surgery, potentially improving survival and cure rates.
- What could go wrong
- This is a small, early-phase trial with only 42 participants, so results may not apply broadly. The drug combo can cause serious side effects like immune reactions, bleeding, or liver damage.
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
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2022
- Expected to finish
-
Dec 2025
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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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 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: * Signed the Informed Consent Form * Ages: 18-75 Years (concluding 18 and 75 Years) * Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma, and meets one of the following conditions: invasion of adjacent organs such as colon, tail of pancreas and spleen; localized peritoneal metastasis; positive exfoliative cytology of ascites; class I, class II, part of class III and very few class IV stage IV gastric adenocarcinoma according to biological behavior; N3; extensive or fused lymph node metastasis; Krukenberg tumor; Liver metastasis limited to one lobe, less than 5cm in diameter, isolated abdominal aortic metastasis, etc; * Untreated(e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) * Life expectancy greater than 3 months * ECOG(Eastern Cooperative Oncology Group) :0\~1 * Sufficient organ and bone marrow functions as follows: 1. Absolute Neutrophil Count (ANC) ≥1.5×109/L, White Blood Cell≥3.5×109/L; 2. Platelet Count of ≥100×109/L; 3. Hemoglobin≥90g/L; 4. Total Bilirubin (TBIL) ≤1.5 x ULN; 5. ALT and AST\<2.5 x ULN, GPT≤1.5×ULN; If there is liver metastasis, then ALT and AST\<5.0 x ULN, GPT≤3.0×ULN; 6. Serum Creatinine (SCr) ≤1.0×ULN; 7. Endogenous creatinine clearance rate \> 60ml / min (Cockcroft Gault formula); * No severe dysfunction of heart, lung and liver; No jaundice and gastrointestinal obstruction; No acute infection * Not participating in other clinical trials 4 weeks before and during the treatment Exclusion Criteria: * Known HER-2 positive * Distal metastasis to lung, brain, and bone * Have received operation on the stomach * A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer * Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment * Previously received allogeneic bone marrow transplantation or organ transplantation * Known hypersensitivity to any of the study drugs or excipients * Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg * International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN * Poorly controlled diabetes before enrollment * Clinically significant electrolyte abnormalities judged by researchers * With any diseases or conditions that affected drug absorption, or the patient could not take drugs orally * Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months * Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50% * Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2) * History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/m) * Women who are pregnant or lactating * Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g * Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions which, according to judgement of the investigator, renders the patient inappropriate for using of the investigational product or may affect interpretation of study results * Patients considered unsuitable for inclusion in this study 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
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Henan Tumor Hospital
Zhengzhou, Henan, 450000, China
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Other studies related to the condition(s) this trial covers.
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