Status:
UNKNOWN
Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. ...
Eligibility Criteria
Inclusion
- Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
- TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
- Expected survival time is over 3 months.
- The age of 18 years old or more.
- According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
- Chemotherapy and/or targeted therapy are planned.
- Signed informed consent.
Exclusion
- History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
- Combined with severe heart, liver, lung and kidney disease.
- Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
- Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
- The expected survival time is less than 3 months.
- The researchers determine that they were not suitable for the study.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05187481
Start Date
November 15 2021
End Date
July 1 2024
Last Update
January 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100053