Clinical study on the treatment of stage III - IV colorectal cancer of spleen deficiency and essence deficiency type with anticancer essence formula

Phase 1

Recruiting

• Conditions: Colorectal cancer

• Registration Number: ITMCTR2000003853
• Lead Sponsor: onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All of the following items are met:
1. Patients with age >= 18 years and < 75 years old;
2. Patients with stage III-IV colorectal cancer confirmed by pathology (see Table 1 for staging criteria), who did not receive targeted therapy and were 1-6 months after the end of chemotherapy;
3. Patients with an estimated survival time of more than 3 months;
4. Patients who have no tumor after radical operation;
5. ECoG activity score was 0 or 1;
6. Patients with spleen deficiency and essence deficiency syndrome.

Exclusion Criteria

1. Patients with other malignant tumor history;
2. Patients with severe cardiovascular and cerebrovascular diseases (such as stroke, myocardial infarction);
3. Patients with severe liver and kidney dysfunction (liver enzymes > 3 times of normal upper limit or estimated glomerular filtration rate < 30ml / min);
4. Patients who have received traditional Chinese medicine treatment within one month;
5. Patients who have participated in or are participating in other clinical studies within three months;
6. Pregnant or lactating women.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of life;

Secondary Outcome Measures

Name	Time	Method
Progression free survival;