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Clinical observation of the effects of Scutellaria decoction combined with 5-FU and irinotecan in the treatment of metastatic colorectal cancers with damp-heat syndrome pattern

Clinical observation of the effects of Scutellaria decoction combined with 5-FU and irinotecan in the treatment of metastatic colorectal cancers with damp-heat syndrome pattern

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017622
Enrollment
Unknown
Registered
2018-08-07
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

colorectal cancer

Interventions

treatment group:modified Scutellaria decoction+5-FU+irinotecan
Control group:5-FU+irinotecan

Sponsors

Eighth People's Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. there are definite histopathological diagnosis and imaging diagnosis; 2. all patients had an evaluable focus; 3. patients who were willing to be treated with chemotherapy and traditional Chinese medicine; 4. aged 18-75 years old, and the sex is not limited; 5. score of ECOG PS 0-2 points; patients who can eat; 6. all cases are expected to survive for more than 3 months; 7. TCM syndrome differentiation belongs to damp heat syndrom pattern.

Exclusion criteria

Exclusion criteria: 1. Lack of imaging or histopathological diagnosis, and the pathological or clinical stages were not clear; 2. Lack of definite lesion or no evaluation of lesions according to RECIST criteria; 3. patients who receive molecular targeted therapy (such as cetuximab, bevacizumab) and palliative surgery in the study phase; 4. women in pregnancy or lactation; 5. patients with severe cardiovascular, cerebrovascular and hematopoietic systems, serious impairment of liver and kidney function, patients with other severe complications, and psychosis patients; 6. patients with fasting or incapable of eating; 7. patients who are expected to live within 3 months of life; 8. patients with ECOG PS>2 score of physical state; 9. all cases that did not conform to the criteria for the entry of the group.

Design outcomes

Primary

MeasureTime frame
Quality of life score;Physical status assessment;Assessment of symptom improvement;Objective remission rate;Disease control rate;Index of toxicity;Safety index;Progression free survival time;

Countries

Chian

Contacts

Public ContactZhang Suqin, Lian Peng

Shanghai Eighth People's Hospital

zhangsuqin2013@163.com+86 17301866157

Outcome results

None listed

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