Colorectal cancer
Conditions
Interventions
Cohort 1:Acceptance of Western medical treatment regimens based on the Chinese Society of Clinical Oncology (CSCO) Colorectal Cancer Diagnosis and Treatment Guidelines (2025 edition), including chemot
Cohort 2:Based on Cohort 1, combined with Qishen Kangyan Formula.
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage IV colorectal malignant tumors confirmed by histopathology or cytology; 2. Patients with a traditional chinese medicine syndrome differentiation of spleen deficiency; 3. Patients aged =18 years and =75 years, with no gender restrictions; 4. Patients with a Karnofsky Performance Status score =60; 5. Patients with an expected survival period of =3 months; 6. Patients with at least one measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 criteria; 7. Patients who voluntarily participate in this study and sign the informed consent form; 8. Patients who have progressed after receiving at least one systemic treatment for metastatic disease, with the last treatment completed =4 weeks prior.
Exclusion criteria
Exclusion criteria: 1. Patients with curable surgical opportunities or potential for conversion; 2. Patients with severe mental disorders or serious underlying conditions such as heart, lung, or brain diseases; 3. Patients with multiple factors affecting oral drug absorption, such as inability to swallow or intestinal obstruction; 4. Patients with any unstable condition or situations that may endanger patient safety or compliance with the study, such as severe mental disorders like schizophrenia; 5. Patients who are about to participate or are currently participating in other clinical trials; 6. Pregnant or breastfeeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free Survival;Overall Survival;Gut microbiota abundance and community composition structure.;Tumor Markers;Lymphocyte subsets;Traditional Chinese Medicine Clinical Syndrome Scoring;Quality of Life Rating; | — |
Countries
China
Contacts
Public ContactYabin Gong Zhenpeng Shi
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Outcome results
None listed