Using Fecal Microbiota Transplantation with Chemotherapy and Immunotherapy for Advanced Gastric Cancer
Official title: Fecal Microbiota Transplantation Combined with SOX and Sintilimab As First-line Treatment for Advanced Gastric Cancer:A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study (FMT-JSNO-01)
Run by Changzhou No.2 People's Hospital · NCT06405113 · Data updated 2026-11-12
This study is testing if adding a fecal microbiota transplant to chemotherapy and immunotherapy helps people with advanced gastric cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 198 (estimated) |
| Sponsor | Changzhou No.2 People's Hospital Academic / other |
| Drugs / interventions | Sintilimab, chemotherapy, immunotherapy |
| Locations | 1 site (Changzhou) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | February 20, 2025 |
| Trial ID | NCT06405113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with unresectable, HER-2 negative advanced gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment.
✕Probably not a fit
Patients with resectable tumors or those who have received prior anti-tumor treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of combining fecal microbiota transplantation (FMT) with a chemotherapy regimen (SOX) and immunotherapy (Sintilimab) as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma. A total of 198 patients who have not received prior treatment will be randomly assigned to either the FMT+SOX+Sintilimab group or the SOX+Sintilimab group. The study will compare the two-year overall survival rates between the two groups to determine if the addition of FMT improves patient outcomes. The trial will be conducted across multiple centers, ensuring a diverse patient population. Safety and efficacy will be closely monitored throughout the treatment process.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced gastric cancer.
How similar studies have gone: While the combination of FMT with chemotherapy and immunotherapy is a novel approach, similar studies have shown promising results in other cancer types, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects aged 18-80 (including 18 and 80 years old); * Understand the research steps and content, and voluntarily sign a written informed consent form; * Non resectable Her-2 negative advanced or metastatic gastric/gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology, excluding all other histological types; * At least one measurable lesion, according to RECIST 1.1 standard; * Have not received anti-tumor treatment in the past; * The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-1; * Expected survival time ≥ 3 months; * Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements (no blood components, cell growth factors, albumin or other corrective drugs are allowed within 14 days prior to obtaining laboratory examination), as follows: 1) Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥75×109/L, hemoglobin (HGB) ≥90 g/L (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: serum total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 5x ULN, serum albumin ≥28 g/L; alkaline phosphatase (ALP) ≤5×ULN; 3) Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/min (using the standard Cockcroft-Gault formula) : Urine routine results showed urinary protein \< 2+; For patients with urine protein ≥2+ at baseline,24-hour urine collection and 24-hour urine protein quantification\<1g should be performed; 4) Coagulation function: International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of anticoagulant drug use. * For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration; * Subjects and their sexual partners are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period. Exclusion Criteria: * Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing; * Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration; * Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; * Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment; * Known allergic reaction to the drug in this study; * Patients requiring long-term systemic use of corticosteroids. Patients with COPD or asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroids could be enrolled; * Symptomatic central nervous metastases. Patients with asymptomatic BMS or BMS whose symptoms are stable after treatment are eligible to participate in this study if they meet all of the following criteria: measurable lesions outside the central nervous system; No midbrain, pontine, cerebellum, meninges, medulla oblongata or spinal cord metastasis; Maintain clinical stability for at least 2 weeks; * Stop hormone therapy 3 days before the first dose of the study drug; * There is an active infection requiring treatment or systemic anti-infective drugs have been used in the week prior to the first dosing; * Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss); * Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); * Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); * Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); * Pregnant or lactating women; * Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.
Where it's running
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Changzhou No.2 People's Hospital
Changzhou, China Recruiting
Study contacts
- Study coordinator: hua jiang
- Email: czeyjh@njmu.edu.cn
- Phone: +86-18015852711
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Conversion therapy using disitamab vedotin (RC48), sintilimab, and SOX for HER2 IHC 1+ or 2+ unresectable gastric cancer
This trial will test whether combining disitamab vedotin (RC48), the immunotherapy sintilimab, and SOX chemotherapy can shrink tumors enough to allow surgery in people with initially unresectable HER2 IHC 1+ or 2+ gastric cancer.
-
IBI343 plus sintilimab and chemotherapy for CLDN18.2-positive gastric or gastroesophageal junction cancer
This trial tests IBI343 combined with sintilimab and standard chemotherapy as a first-line treatment for adults with CLDN18.2-positive, HER2-negative advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
-
Using immune checkpoint inhibitors to preserve organs in non-metastatic gastric or colon cancers
This study is testing a new combination of immune treatments to see if it can help people with non-metastatic gastric or colon cancers keep their organs and improve their health before surgery.
-
Sintilimab combined with chemoradiotherapy for elderly patients with advanced gastric cancer
This study is testing if a new combination of a drug called sintilimab with chemotherapy and radiation can help older patients with advanced stomach cancer feel better and improve their quality of life.
-
Neoadjuvant therapy for HER2 positive locally advanced gastric cancer
This study is testing a new treatment plan that combines radiation and medications to see if it can help people with advanced stomach cancer get ready for surgery.
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Combining Sintilimab with Chemoradiotherapy for Advanced Gastric Cancer
This study is testing if combining an immunotherapy drug called Sintilimab with chemotherapy and radiotherapy can safely help people with advanced gastric cancer before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.