Clinical trial NCT05187481: Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
Official title: Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: colorectal cancer
traditional Chinese medicine
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Academy of Chinese Medical Sciences
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted: 2022-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.


Eligibility criteria: Inclusion Criteria:

1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
2. TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
3. Expected survival time is over 3 months.
4. The age of 18 years old or more.
5. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
6. Chemotherapy and/or targeted therapy are planned.
7. Signed informed consent.

Exclusion Criteria:

1. 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.
2. Combined with severe heart, liver, lung and kidney disease.
3. 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.
4. 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.
5. The expected survival time is less than 3 months.
6. The researchers determine that they were not suitable for the study.

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 100 months
Secondary outcomes:
measure: Survival rate
timeFrame: 3 years
measure: Disease control rate
timeFrame: 3 months
measure: Cancer fatigue score
timeFrame: 3 months
measure: Traditional Chinese Medicine(TCM )symptom grading table
timeFrame: 3 months
measure: The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
timeFrame: 3 months
measure: the United States Eastern Oncology Collaboration Group (ECOG) score scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Yu Wu, Master
role: STUDY_CHAIR
References: