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Clinical study on regulating immune cells by Yiqi Huayu Jiedu to reduce the risk of recurrence and metastasis of colorectal cancer after operation

Clinical study on regulating immune cells by Yiqi Huayu Jiedu to reduce the risk of recurrence and metastasis of colorectal cancer after operation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000268
Enrollment
Unknown
Registered
2025-02-15
Start date
2024-08-08
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

colorectal cancer

Interventions

2:chemotherapy+TCM

Sponsors

Department of Oncology Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The pathological diagnosis was in line with the diagnostic criteria of colorectal cancer and the syndrome differentiation of TCM was spleen deficiency and stasis; (2) Patients with pathological stage III who have undergone radical surgery; (3) ECOG score =2 points aged between 18-75 years old; (4) The expected survival time is more than 6 months; (5) Sign informed consent. Volunteer to take the test. The process of obtaining informed consent shall comply with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Patients with metastatic colorectal cancer; (2) Local recurrence or distant metastasis has been confirmed by histopathology or imaging examination; (3) pregnant and lactating women; (4) severe primary cardiovascular disease liver disease kidney disease hematological disease; (5) have serious primary heart liver lung kidney blood or serious diseases affecting their survival; (6) Persons with disabilities defined by law (blind deaf mute mentally handicapped mentally handicapped physically handicapped); (7) Suspected or have a history of alcohol and drug abuse; (8) Other diseases that reduce the possibility of enrollment or complicate enrollment such as frequent changes in the working environment are likely to cause loss of follow-up according to the judgment of the investigator; (9) allergies such as allergies to two or more drugs or food; Or known allergy to the ingredients of the drug; (10) Patients who are participating in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
Cytokine detection;disease-free survival;Cell immune function test;1-year and 2-year progression-free survival rates;

Secondary

MeasureTime frame
Overall chemotherapy completion rate;Tumor markers;Quality of life score;TCM syndrome scores;

Countries

China

Contacts

Public ContactYuwen Zhuang

Jiangsu Province Hospital of Chinese Medicine

zhuangyuwen21@126.com+86 18512526403

Outcome results

None listed

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