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A clinical study on the combination of geniposide LI and chemotherapy in the treatment of advanced colon cancer based on metabolomics

A clinical study on the combination of geniposide LI and chemotherapy in the treatment of advanced colon cancer based on metabolomics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000008
Enrollment
Unknown
Registered
2025-01-03
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

Research group:Oral administration of Gynostemma pentaphyllum saponin tablets on the basis of FOLF0X6 regimen or XELOX regimen treatment

Sponsors

Changzhou Second People's Hospital Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. According to the UICC/AJCC 8th edition TNM staging of colon cancer, the diagnosis of histopathology or cytology is IV Patients with stage colon malignant tumors; 2. Between the ages of 18 and 80; 3. At least one measurable lesion, according to RECIST 1.1 standard; 4. Frontline systemic anti-tumor treatment or entering the maintenance treatment stage; 5. ECOG score 0-1 points; 6. No autoimmune diseases; 7. Not using high-dose hormones and long-term antibiotics; 8. Expected survival time = 3 months;

Exclusion criteria

Exclusion criteria: 1. Unable to cooperate due to mental illness; 2. Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; Use high-dose glucocorticoids or immune transplant agents or long-term antibiotics within 3.4 weeks; Patients participating in other clinical trials within 4.4 weeks; 5. Patients with infectious pneumonia, non infectious pneumonia, interstitial pneumonia, and other conditions that require the use of corticosteroids; 6. Have a serious history of chronic autoimmune diseases, such as systemic lupus erythematosus, etc; A history of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and a history of chronic diarrhea diseases such as irritable bowel syndrome; Have a history of sarcoidosis or tuberculosis History; 7. Patients who do not follow medical advice, do not use medication according to regulations, or have incomplete information that can affect the judgment of efficacy or safety; 8. According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study;

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Overall Survival;Progression Free Survival;

Countries

China

Contacts

Public Contactdingjie

Changzhou Second People's Hospital Jiangsu Province

shuikui1705@163.com+86 158 5196 3847

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026