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Clinical study on strengthening spleen and relieving toxin decoction combination with first-line chemotherapy maintenance treatment for mCRC

Clinical study on strengthening spleen and relieving toxin decoction combination with first-line chemotherapy maintenance treatment for mCRC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-IOC-16007711
Enrollment
Unknown
Registered
2016-01-05
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

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 and control group: strengthening spleen and relieving toxin decoction combination with first-line chemotherapy

Sponsors

ShuGuang Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: All patients who were included in the trial were to meet all of the following conditions: 1. Clear cytology or pathology diagnosis of mCRC, the operation or imaging examination stage for the IV period; 2. The bank has been the first-line chemotherapy treatment and access to CR, PR, SD with the expected survival time more than 6 months of the initial treatment of patients; 3. There are at least 1 imaging examinations (PET-CT, CT, MRI, bone scan, X-ray) showed measurable lesions; 4. With the spleen deficiency and dampness heat syndrome diagnosis; 5. The men and women, aged 18-75 years old. Body condition score ECOG (0 ~ 1) or KPS = 70; 6. The peripheral blood of normal liver and kidney function, no obvious abnormal ECG is normal. Indications for maintenance chemotherapy; 7. The patients with good compliance, can understand the research situation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Does not conform to the diagnosis and inclusion criteria, the diagnosis of unknown; 2. There are serious diseases of the cardiovascular system, urinary system diseases, blood system diseases, digestive system diseases, and can not withstand the test; 3. A mental disorder, which is difficult to control during pregnancy or lactation; 4. With the activities of tuberculosis and other serious infectious diseases; 5. We should not oral drugs or frequent vomiting; 6. The difference between the compliance; 7. To treat or use other drugs or other trial patients in a clinical trial can not be selected within the target in January.

Design outcomes

Primary

MeasureTime frame
PFS;Disease remission rate;

Secondary

MeasureTime frame
cytokine;cellular immunity;

Countries

China

Contacts

Public ContactFu Xiaoling
fuxiaoling111@163.com+86 13917953726

Outcome results

None listed

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