Gastric CancerPhase 2NCT06405113
FMT+SOX+Sintilimab As First-line Treatment for Advanced Gastric Cancer
A Phase 2 study testing Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy in people with Gastric Cancer, run by Changzhou No.2 People's Hospital at 1 site in China.
Trial summary
the investigators plan to initiate a prospective, multicenter, randomized, double-blind, placebo-controlled phase II study, recruiting 198 patients with advanced gastric/gastroesophageal junction adenocarcinoma who have not received prior treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changzhou No.2 People's Hospital
Changzhou
Hua Jiang
About this study
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)
the investigators plan to initiate a prospective, multicenter, randomized, double-blind, placebo-controlled phase II study, recruiting 198 patients with advanced gastric/gastroesophageal junction adenocarcinoma who have not received prior treatment. Randomly divided into two groups, one group is the group of fecal microbiota transplantation(FMT)+SOX+Sintilimab, and the other group is the group of SOX+Sintilimab. Compare the 2-year OS rates of the two groups to verify whether the addition of FMT to first-line treatment can improve the prognosis of gastric cancer patients.
Read the detailed description
the investigatorse plan to initiate a prospective, multicenter randomized, double-blind, placebo-controlled phase II study, recruiting a total of 198 patients with previously untreated unresectable advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in our hospital and 14 other hospitals. Randomly divided into Group A and Group B, Group A received FMT+SOX chemotherapy regimen +Sintilimab immunotherapy regimen, Group B only received SOX chemotherapy regimen+and Sintilimab immunotherapy regimen. If there is no progression of the disease after 4-6 cycles of first-line treatment, both groups of patients will enter the first-line maintenance treatment stage: S-1+Sintilimab, until disease progression, intolerance, or death occurs. The aim is to explore the efficacy and safety of FMT combined with SOX and Sintilimab in the treatment of advanced first-line gastric cancer patients.
- Conditions
- Gastric Cancer
- Being tested
- Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyCombination product
Participants received Fecal Microbiota Transplantation (FMT) combined with (Oxaliplatin + S-1)+Sintilimab
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Fecal Microbiota Transplantation(FMT)+SOX+Sintilimab Receives: Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy |
| Placebo Comparator Arm | Placebo comparator | Placebo+SOX+Sintilimab Receives: Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival rate(2year-OS Rate)
The proportion of patients who have not died after 2 years of treatment
Measured: up to 24 months
Secondary outcomes (5)
Median Progression-Free Survival (mPFS)
Observation for mPFS will be recorded until the end of follow-up after the start of 1st cycle of treatment.
Measured: up to 24 months
Objective Response Rate (ORR)
Objective response rate will be assessed by investigators.
Measured: up to 24 months
Incidence of Adverse events (AEs)
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: up to 24 months
The Diversity of Fecal Microbiota
This will be detected by 16s rRNA sequencing or metagenomes.
Measured: up to 24 months
Quality of Life (QoL)
QoL will be evaluated by EORTC-QLQ-C30.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou No.2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Jiang, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405113
- Sponsor's protocol ID
- [2024]YLJSA001
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06405113
- Acronym / sponsor ID
- [2024]YLJSA001
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Changzhou No.2 People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the investigators plan to initiate a prospective, multicenter, randomized, double-blind, placebo-controlled phase II study, recruiting 198 patients with advanced gastric/gastroesophageal junction adenocarcinoma who have not received prior treatment. Randomly divided into two groups, one group is the group of fecal microbiota transplantation(FMT)+SOX+Sintilimab, and the other group is the group of SOX+Sintilimab. Compare the 2-year OS rates of the two groups to verify whether the addition of FMT to first-line treatment can improve the prognosis of gastric cancer patients.
Detailed description
the investigatorse plan to initiate a prospective, multicenter randomized, double-blind, placebo-controlled phase II study, recruiting a total of 198 patients with previously untreated unresectable advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in our hospital and 14 other hospitals. Randomly divided into Group A and Group B, Group A received FMT+SOX chemotherapy regimen +Sintilimab immunotherapy regimen, Group B only received SOX chemotherapy regimen+and Sintilimab immunotherapy regimen. If there is no progression of the disease after 4-6 cycles of first-line treatment, both groups of patients will enter the first-line maintenance treatment stage: S-1+Sintilimab, until disease progression, intolerance, or death occurs. The aim is to explore the efficacy and safety of FMT combined with SOX and Sintilimab in the treatment of advanced first-line gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyFecal Microbiota Transplantation(FMT)+SOX+Sintilimab |
| Placebo Comparator Arm | Placebo comparator | Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyPlacebo+SOX+Sintilimab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyParticipants received Fecal Microbiota Transplantation (FMT) combined with (Oxaliplatin + S-1)+Sintilimab | Combination product | Experimental Arm, Placebo Comparator Arm |
Primary outcome
2-year overall survival rate(2year-OS Rate)
Time frame: up to 24 months
The proportion of patients who have not died after 2 years of treatment
5 secondary outcomes
Median Progression-Free Survival (mPFS)
Time frame: up to 24 months
Objective Response Rate (ORR)
Time frame: up to 24 months
Incidence of Adverse events (AEs)
Time frame: up to 24 months
The Diversity of Fecal Microbiota
Time frame: up to 24 months
Quality of Life (QoL)
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy in people with Gastric Cancer, run by Changzhou No.2 People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hua jiang (+86-18015852711, czeyjh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival rate(2year-OS Rate) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.