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

NCT05065515 | Unknown

• 1 other identifier: KY20212109-C-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiota

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (1)

• The relative abundance of species

  6 months

Other Outcomes (1)

• Species richness

  6 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;
• 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:
• (1) 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:
• a) 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Jianjun Yang

Xi'an, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

treatment and control groups' feces and a small amount of blood

Study Officials

• Jianjun Yang, Dr

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianjun Yang, Dr

CONTACT

0086-13572533693; jianjunyang66@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 4, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-09

Locations

CN (1)