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Clinical study on the prevention of postoperative recurrence and metastasis of colorectal cancer by Zuojin pill combined with adjuvant chemotherapy

Phase 1
Recruiting
Conditions
colorectal cancer
Registration Number
ITMCTR2000003349
Lead Sponsor
Shuguang Hospital affillated with Shanghai University of TCM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Clear cytology and pathology diagnosis of colorectal cancer (TMN stage for III);
2. The TCM syndrome type was consistent with the syndrome of irascibility in stomach and gastrointestinal dampness and heat.
3. Chemotherapy was planned, and there were no other treatment plans such as radiotherapy, interventional therapy, targeting and immunization during the study period.
4. 1 month before the test, no traditional Chinese medicine, proprietary Chinese medicine or traditional Chinese medicine injection was used for the treatment.
5. Urine HCG test is available for both men and women, aged 18-80 years and of childbearing age.
6. Physical condition score: KPS score: 70 or above;
7. The estimated survival time is 6 months or more;
8. The peripheral blood image was normal, and there were no obvious abnormalities in the cardiac, hepatic, renal and electrocardiogram.
9. No cognitive impairment, willing to participate in this study, able to receive relevant treatment and physical and chemical examinations and sign an informed consent.

Exclusion Criteria

1. Patients with serious diseases such as cardiovascular system, respiratory system, digestive system, urogenital system, blood system and rheumatic immune system, who cannot tolerate treatment;
2. People with mania, depression, anxiety, schizophrenia, active tuberculosis and other serious infectious diseases;
3. Cancer pain, intestinal obstruction, ascites and other serious tumor complications;
4. Patients who had received radiotherapy, interventional therapy, targeted therapy, immunization and other treatments in the past 2 months;
5. Those who had been enrolled in other experimental drugs in the past 2 months;
6. Those who cannot be treated by TCM compound due to allergy or other reasons;
7. The researcher considers it inappropriate to participate in the study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
recurrence rate;
Secondary Outcome Measures
NameTimeMethod
Tumor markers;the TCM symptom effect;KPS;QLQ-C30;PFS;
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