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Gut MicrobiotaNCT05065515

Establishment of Individualized Immunotherapy Strategy and Platform Based on Changes of Intestinal Microbiota

An observational study of Gut Microbiota, run by Xijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore and analyze the relationship between intestinal flora changes and the efficacy of individualized immunotherapy in patients with upper gastrointestinal cancer, and to find new biomarkers to predict the efficacy of immunotherapy, bringing new breakthroughs in tumor diagnosis and treatment. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Gut Microbiota
How many people
40 participants
Where
1 siteChina
Study dates
1 Oct 2021to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Age: 18-80 years old, no gender limit;

Who may be able to join

  • Age: 18-80 years old, no gender limit;
  • BMI index 18.5-23.9kg/m2;
  • Patients with esophageal squamous cell carcinoma, gastric adenocarcinoma or gastrointestinal stromal tumor diagnosed by pathology;
  • Patients who intend to undergo individualized immunotherapy, who have not undergone surgery in the past;
  • Patients with advanced or unresectable upper gastrointestinal tumors according to clinical stage;
  • ECOG score: 0-1 points;
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  • Estimated survival period ≥ 3 months;
  • All patients should have measurable or evaluable target lesions;
  • Able to eat a liquid diet or above; no complete obstruction or perforation of the digestive tract; no distant metastasis;
  • The main organs are functioning normally, that is, they meet the following standards:
  • Routine blood examination standards must meet (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):
  • HB≥80 g/L;
  • ANC≥1.5×109/L;
  • PLT≥100×109/L; (2) The biochemical inspection shall meet the following standards:
  • TBIL<1.5×ULN; b) ALT and AST<2.0×ULN; c) Serum Cr≤1.5×ULN or endogenous creatinine clearance> 50 mL/min (Cockcroft-Gault formula); (3) Pulmonary function assessment: Pulmonary function is normal or mild to moderately abnormal (VC%>60%, FEV1>1.2L, FEV1%>40%, DLco>40%); (4) Cardiovascular function assessment: cardiac function grade Ⅰ～Ⅱ; 11. Have a certain degree of self-care ability and language comprehension ability;

Who cannot join

  • Patients with pathological types and primary foci that do not meet the inclusion criteria;
  • People who are known to be allergic to macromolecular protein preparations, or to immunological preparations and contrast agents and their preparation components;
  • Risk of digestive tract perforation;
  • Evidence of distant organ metastasis;
  • Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed;
  • Have suffered from other malignant tumors;
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  • History of serious lung or heart disease;
  • Have active infection or have fever of unknown cause > 38.5℃ within 2 weeks prior to randomization (according to the judgment of the investigator, the subjects' fever due to tumor can be included in the study);
  • Significant active infection is known, or significant blood, renal, metabolic, gastrointestinal, or endocrine dysfunction is determined by the investigator;
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
  • The subject has active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody and hcV-RNA higher than the detection limit of analysis method);
  • Those who received live vaccine within 3 months prior to treatment;
  • Patients with acute or chronic tuberculosis infection (positive t-spot test, suspicious tuberculosis foci on chest X-ray);
  • History of drug, drug or alcohol abuse (drinking ≥5 times a week, ≥2 liang of liquor each time, etc.);
  • The patient participated in clinical trials of other antineoplastic agents within 4 weeks;
  • No intravenous infusion;
  • Severe diarrhea in the past 2 months (≥3 watery stools per day for ≥3 days);
  • Severe constipation in the past 2 months (defecation ≤2 times per week, with difficulty defecating);
  • Used antibiotics for 3 days or more in the past 2 months;
  • Used proton pump stomach drugs, acid suppressants, mucosal protectants, opioid psychotropic drugs, hormones, immunosuppressants, cytotoxic drugs and other drugs within the past 2 months for 3 days or more;
  • Used probiotics, prebiotics or biosaccharides for 3 days or more in the past 2 months;
  • Abnormal thyroid function caused by cholecystitis, gastrointestinal ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other diseases within the past 1 month;
  • Medical procedures such as gastrointestinal surgery, appendicitis surgery or enema or bowel cleansing have been performed within the past 1 year;
  • Lactose intolerance during pregnancy and lactation (female);
  • Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);A history of unstable angina pectoris;Patients who were newly diagnosed with angina pectoris within 3 months before screening or had myocardial infarction within 6 months before screening;Arrhythmias (including QTcF: ≥450 ms for men and ≥470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association classification ≥II cardiac insufficiency;
  • In the investigator's judgment, the subject has other factors that may cause him/her to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, seriously abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of test data;
  • The investigator determines other conditions that may affect the conduct of the clinical study and the determination of the study results;
  • Partners or first-degree relatives of research centre staff, researchers;

Trial locations and contacts

1 site in 1 country.

Jianjun Yang, Dr contact

0086-13572533693

jianjunyang66@hotmail.com

China1 site, 1 recruiting

  • Jianjun Yang

    Xi'an

    Jianjun Yang, Dr

    Recruiting

Other trials in China

About this study

Official title: Establishment of Individualized Immunotherapy Strategy and Platform for Upper Gastrointestinal Cancer Based on Changes of Intestinal Microbiota

To explore and analyze the relationship between intestinal flora changes and the efficacy of individualized immunotherapy in patients with upper gastrointestinal cancer, and to find new biomarkers to predict the efficacy of immunotherapy, bringing new breakthroughs in tumor diagnosis and treatment.

Read the detailed description
  1. Compare the composition of intestinal flora of patients before and after immunotherapy and in patients with different therapeutic effects of immunotherapy.
  2. Combine the results above with the patient's blood sample, which is carried out from the metabolic level.
  3. Combine the pathological data of the patient to determine the staging and pathological types, and use blood samples to detect metabolites to find out different metabolites.
  4. the metabolic data and the flora data are associated with the analysis to find the bacteria species with higher correlation with the differential metabolites to guide the subsequent animal experiments.
Conditions
Gut Microbiota

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree of tumor regression

    We used the RECIST 1.1 evaluation criteria to evaluate the response to the immune therapy and accordingly divided patients into two groups，Response and No Response.

    Measured: 6 months

Secondary outcomes (1)

  1. The relative abundance of species

    Use polymerase chain reaction (PCR) to specifically expand Increase the V3-V4 variable region of 16SrRNA and perform community analysis

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start1 Oct 2021
  3. Primary completionOct 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065515
Sponsor's protocol ID
KY20212109-C-1
Status last verified
Sep 2022
First submitted
16 Sep 2021
Last updated
14 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gut Microbiota, run by Xijing 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 15 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianjun Yang, Dr (0086-13572533693, jianjunyang66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of tumor regression (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065515.

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 14 Nov 2022.

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