Coloractal cancer
Conditions
Interventions
chemotherapy alone group.:Use FOLFOX or CapeOx first-line chemotherapy regimen, with at least 6 cycles of chemotherapy
Jianpijiedu decoration combined with chemotherapy group.:Based on the first-line chemotherapy regimen of FOLFOX or CapeOx, patients will start taking Traditional Chinese Medicine Jianpi Jiedu Formula
Sponsors
Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
19 Years to 74 Years
Inclusion criteria
Inclusion criteria: (1)Patients with primary gastrointestinal tumors confirmed by clear pathological or cytological examinations, including primary esophageal tumors, primary gastric tumors, primary small intestinal tumors, primary colorectal tumors, primary anal tumors, and primary pancreatic tumors. (2)Patients requiring chemotherapy due to malignant tumors; (3)Clear TNM staging (AJCC 8th Edition Clinical Staging); (4)Age: Over 18 years and under 75 years, regardless of gender; (5)Patients in good physical condition, with a Karnofsky performance status score of =60, and an estimated survival of more than 3 months; (6)No contraindications for chemotherapy, meeting the indications and basic requirements for chemotherapy, including essentially normal peripheral blood counts, no significant abnormalities in heart, liver, and kidney functions, and essentially normal electrocardiograms; (7)Subjects voluntarily participating in the clinical trial, signing the informed consent form, and demonstrating good compliance.
Exclusion criteria
Exclusion criteria: (1)Patients using targeted drugs simultaneously; (2)Patients currently undergoing or preparing to receive radiation therapy or immunotherapy; (3)Patients with other immune system diseases or those who have recently used immunomodulatory drugs; (4)Patients with frequent vomiting or those who refuse to take traditional Chinese medicine; (5)Patients with severe organic diseases of vital organs and serious primary diseases of the hematopoietic system, as well as those with other diseases under medication that may affect the observation of the trial drug, psychiatric disorders, or dementia; (6)Pregnant or breastfeeding women; those with a history of severe allergies or drug allergies; (7)Patients who have participated in other drug clinical trials within the 4 weeks prior to the trial; (8)Individuals who cannot or are unwilling to provide informed consent or comply with trial requirements; (9)Patients with other malignant tumors in addition to the primary tumor; (10)Individuals who have lost more than 6% of their weight in the past 5 months, or those who have lost 2%-5% of their weight, with a BMI of <20 kg/m² or reduced muscle mass; (11)Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Clinical Symptom Scoring;KarnofskyPerformance Status rating;Quality of Life rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemotherapy Response Status;tumor markers;Improvement in Behavioral Status and Immune Function;Changes in Blood Parameters Before and After Treatment;Comprehensive Therapeutic Efficacy of Disease Syndromes;Changes in Gut Microbiota Before and After Treatment;Changes in Blood Metabolomics Before and After Treatment;Incidence of Acute and Subacute Toxicity Adverse Reactions;Changes in Body Weight; | — |
Countries
China
Contacts
Public ContactSifang Zhang
Second Xiangya Hospital, Central South University
Outcome results
None listed