The Mechanism of Enhancing the Anti-tumor Effects of CAR-T on PC by Gut Microbiota Regulation
NCT ID: NCT04203459
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2019-10-20
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pancreatic cancer patient
(1) patients with pancreatic cancer confirmed by imaging, pathology and body fluid biopsy, or patients who recovered well one month after operation but still had residual lesions, recurrence or metastasis. ② age ≥ 30 and ≤ 75. ③ no chemotherapy, radiotherapy or targeted drugs were used before admission. ④ patients who had used immunosuppressive drugs, hormones, antibiotics and probiotics one month before admission were excluded. ⑤ patients with HIV positive and active hepatitis B or C infection were excluded. ⑥ exclude the previous history of other malignant tumors or the current combination of other malignant tumors. The patients with serious cardiopulmonary disease and liver and kidney dysfunction were excluded. ⑧ patients with obstructive jaundice were excluded.
No interventions assigned to this group
Healthy person
(1) no history of digestive tract diseases, infectious diseases or immune diseases.(2) no history of smoking or drinking.(3) did not take antibiotics and other drugs and probiotics for 1 month before enrollment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. age ≥ 30 and ≤ 75
3. the estimated life span is more than 1 month.
4. Karnofsky score ≥ 60; ECoG ≤ 2
5. the function of important organs: Echocardiography indicated that the ejection fraction of heart was ≥ 50%; ECG showed no obvious abnormality; creatinine clearance rate calculated by Cockcroft Gault formula was ≥ 40ml / min; ALT and AST were ≤ 3 times of normal value; total bilirubin was ≤ 2.0mg/dl; coagulation function: Pt and appt were \< 2 times of normal value; arterial oxygen saturation (SpO2) \> 92%;Blood routine test: Hgb ≥ 80g / L, ANC ≥ 1 × 109 / L, PLT ≥ 50 × 109 / L.
6. sign the informed consent.
1. no history of digestive tract diseases, infectious diseases or immune diseases.
2. no history of smoking or drinking.
3. did not take antibiotics and other drugs and probiotics for 1 month before enrollment.
Exclusion Criteria
2. serious active infection.
3. HIV positive, active hepatitis infection.
4. previous history of other malignant tumors. Excluding: Patients with cured skin basal or squamous cell carcinoma and cervical carcinoma in situ at any time before the study; patients with other tumors not listed above but cured by operation only without other further treatment measures and disease-free survival period ≥ 5 years can be included in the study.
(6) patients participating in other clinical trials at the same time. (7) in the opinion of the researcher, the subjects are not suitable to be selected or cannot cooperate to participate in or complete the study.
1. patients who had used immunosuppressive drugs, hormones, antibiotics and probiotics in the first month before inclusion.
2. severe active infection.
3. human immunodeficiency virus (HIV) positive, active hepatitis infection.
4. previous history of other malignant tumors. Excluding: patients with cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Subjects with disease-free survival ≥5 years of other tumors not listed above, which have been cured by surgery only without other further treatment measures, can be included in the study.
(6) patients who also participate in other clinical trials. (7) the investigator considers that the subject is not suitable for inclusion or unable to cooperate in or complete the study.
30 Years
75 Years
ALL
Yes
Sponsors
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First Affiliated Hospital of Harbin Medical University
OTHER
Responsible Party
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Locations
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The first affiliated hospital of Harbin medical university
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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Lei Zhao
Role: primary
Other Identifiers
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Yunwei Wei 2019-10-20
Identifier Type: -
Identifier Source: org_study_id