Zuojinwan Combined With Chemotherapy and Cetuximab for Advanced Colorectal Cancer: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Phase 1

Recruiting

• Conditions: colorectal cancer

• Registration Number: ITMCTR2000003940
• Lead Sponsor: Shuguang Hospital, 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

1. Patients who are diagnosed as colorectal cancer by pathology, cytology or imaging, and whose histological type is carcinoma, mucinous adenocarcinoma, signet ring cell carcinoma;
2. Colorectal cancer patients with stage IV according to AJCC staging;
3. RAS, BRAF wild-type, advanced unresectable colorectal cancer patients receiving chemotherapy combined with cetuximab;
4. After PET-CT, CT, MRI, bone scan and other imaging examinations, there is at least one measurable lesion;
5. TCM syndrome differentiation belongs to the syndrome of liver fire offending the stomach;
6. 18 years old <= age <= 80 years old;
7. KPS >= 60 points;
8. Estimated survival time >= 3 months;
9. Blood routine, liver function, kidney function, and heart function are generally normal, in line with chemotherapy indications;
10. Have good compliance and sign informed consent to cooperate with this research.

Exclusion Criteria

1. Combined with other primary tumors;
2. Patients with severe cardiovascular and cerebrovascular diseases or severe mental illness;
3. Those who have used chemotherapy or Chinese medicine for less than 2 cycles;
4. Patients with active tuberculosis or infection;
5. Those who are unable to take drugs orally;
6. Those who have poor compliance and cannot complete the research;
7. Those who have participated in other clinical trials in the past month.
8. Women during pregnancy or breastfeeding.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
progression free survival;

Secondary Outcome Measures

Name	Time	Method
Quality of Life;overall survival;