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רדאר קליני AI
הניסוי הקליני NCT07477522 עבור Colorectal Cancer (Diagnosis), Diet Habits, High-fibre Diet הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים

Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study שלב I 25 אימונותרפיה בינלאומי תזונה

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT07477522 מתקיים כדי לבדוק את טיפול עבור Colorectal Cancer (Diagnosis), Diet Habits, High-fibre Diet. זהו מחקר שלב I מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-31 באוקטובר 2025 ומתוכנן לכלול 25 משתתפים. המחקר מנוהל על ידי West China Hospital וצפוי להסתיים ב-30 ביוני 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-17 במרץ 2026.
סיכום קצר
Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, >90 % being solid cancers. Lung cancer alone accounted for 2.2 million new cases and 1.8 million deaths; >75 % of patients were already at an advanced stage at di...הצג עוד
כותרת רשמית

Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study

מצבים רפואיים
Colorectal Cancer (Diagnosis)Diet HabitsHigh-fibre Diet
מזהי מחקר נוספים
  • Approval No. 1038 (2025)
מספר NCT
תחילת המחקר (בפועל)
2025-10-31
עדכון אחרון שפורסם
2026-03-17
סיום המחקר (מוערך)
2026-06-30
משתתפים (מתוכנן)
25
סוג המחקר
התערבותי
שלב
שלב I
סטטוס
מגייס
מילות מפתח
high-fibre diet
Colorectal Cancer
מטרה ראשית
טיפול
הקצאת טיפול
לא ישים
דגם מתערב
קבוצה יחידה
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיhigh-insoluble-fibre diet
High-fibre Diet
Dietary fibre, recommended at 25-30 g/d (15-21 g insoluble), is chronically under-consumed (\~11 g/d in China). High-fibre diets increase SCFAs, enhance gut-barrier integrity and boost anti-tumour immunity, correlating with better immunotherapy outcomes in melanoma. Clinical evidence in solid tumours is lacking. Our trial will test whether \>21 g/d insoluble fibre reshapes microbiota, metabolites and immune markers i...הצג עוד
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Evaluate the safety and tolerability of High-fibre diet in patients with solid tumors.
The occurrence types, frequencies, and severities of treatment - emergent adverse events (TEAE).
From enrollment to the end of treatment at 6 weeks
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Objective Response Rate (ORR)
Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.
From enrollment to the end of treatment at 1 year
Disease Control Rate (DCR)
Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors.
From enrollment to the end of treatment at 1 year
Duration of Response (DoR)
Evaluate the effectiveness of arginine - restricted diet in patients with solid tumors
From enrollment to the end of treatment at 1 year
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • (1) Sign a written informed consent form before any study - related procedures are carried out.

    (2) Males or females, aged 18 - 80 years old. (3) Diagnosed with solid tumors by pathological tissue biopsy. (4) According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) criteria, there is at least 1 measurable lesion (lesions previously treated with local therapies such as radiotherapy cannot be regarded as measurable lesions).

    (5) ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0 - 1.

    (6) NRS - 2002 (Nutritional Risk Screening 2002) score < 3. (7) BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual situation).

    (8) Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition.

    (9) Sufficient organ function, and the subjects need to meet the following laboratory indicators: In the absence of granulocyte - colony - stimulating factor use in the past 14 days, the absolute neutrophil count ≥ 1.5×10⁹/L.

Platelets ≥ 75×10⁹/L. In the absence of blood transfusion or erythropoietin use in the past 7 days, hemoglobin ≥ 8 g/dL.

Serum albumin ≥ 3.0 g/dL. Total bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN. In case of liver metastasis, ALT and/or AST ≤ 5×ULN, and total bilirubin ≤ 3×ULN. In case of liver or bone metastasis, Alkaline Phosphatase (AKP) ≤ 5×ULN.

Creatinine clearance rate ≥ 50 mL/min (calculated according to the Cockcroft - Gault formula) or serum creatinine ≤ 1.5×ULN.

International Normalized Ratio (INR) ≤ 1.5×ULN, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN.

Urine protein < 2+ (if urine protein ≥ 2+, a 24 - hour urine protein quantification can be performed, and subjects with a 24 - hour urine protein quantification < 2.0 g can be enrolled).

(10) Women of child - bearing potential must agree to avoid sexual intercourse (heterosexual intercourse) or use a reliable and effective contraceptive method from the signing of the informed consent form until at least 6 months after the last administration of the study drug. In addition, the serum HCG (Human Chorionic Gonadotropin) test must be negative within 3 days before the start of the study treatment, and the subject must be non - lactating. A female patient is considered to be of child - bearing potential if she is post - menopausal but has not reached the post - menopausal state (non - menstrual period ≥ 12 consecutive months, and no other causes are found except menopause) and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

(11) If there is a risk of pregnancy, all subjects (regardless of male or female) need to use a contraceptive method with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug)

  • (1) Patients with cognitive impairment or mental illness who are unable to understand the study content.

    (2) Patients with central nervous system or meningeal metastases. (3) Patients with clinically symptomatic moderate or severe ascites (that is, those who require therapeutic paracentesis within 2 weeks before the start of study treatment; patients with only a small amount of ascites shown on imaging and no clinical symptoms can be enrolled).

    (4) Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.

    (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or abdominal abscess; patients with extra - gastrointestinal bleeding with a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of study treatment or grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis).

    (6) Patients known to be allergic to the active ingredients or excipients of the study drug.

    (7) Patients with poorly controlled diabetes. (8) Patients with poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg under routine antihypertensive treatment), with a history of hypertensive crisis or hypertensive encephalopathy.

    (9) Patients with severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis); patients with poorly controlled clinical symptoms or heart diseases, such as unstable angina pectoris, NYHA (New York Heart Association) heart failure grade II or above, left ventricular ejection fraction < 50% on color Doppler echocardiography, or severe arrhythmias that cannot be controlled by drug treatment.

    (10) Pregnant or lactating women. (11) Other situations considered by the investigator as inappropriate for enrollment.

West China Hospital logoWest China Hospital
הגורם האחראי למחקר
Xuelei Ma MD, חוקר ראשי, Deputy Director (Medical) of the Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University; Associate Director of the Stem Cell Research and Translational Research Laboratory; PhD Supervisor; Professor/Researcher
איש קשר מרכזי למחקר
איש קשר: Jingwen Wei, 8283095730, [email protected]
1 מיקומי המחקר ב-1 מדינות

Sichuan

West China Hospital, Chengdu, Sichuan, China
Jingwen Wei, איש קשר, 8283095730, [email protected]
מגייס