colorectal neoplasia
Conditions
Interventions
control group:Conventional treatment
treatment group:Conventional treatment + Liushen pills
Sponsors
Nanjing Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: (1) Advanced colorectal cancer patients with definite pathological diagnosis; (2) measurable lesions; (3) TCM clinical syndrome differentiation is the syndrome of damp-heat accumulation; (4) The first chemotherapy regimen or the first change of chemotherapy regimen to XELOX (oxaliplatin + capecitabine) or mFOLFOX6 (oxaliplatin + calcium folinate + 5-fluorouracil) combined with targeted drug therapy after the last chemotherapy failure; (5) 18 years old =78 years old gender is not limited; (6) ECOG score 0~2 points; (7) Expected survival =3 months; (8) The subjects voluntarily joined the study signed the informed consent had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: (1) Primary malignant tumors combined with other systems; (2) Combined with serious heart brain liver kidney and other primary diseases or serious diseases affecting their survival; (3) Patients with combined immune system diseases; (4) Patients who are allergic to chemotherapy drugs or experimental drugs (known components) and excipients of this program; (5) Mental or cognitive impairment poor compliance unable to cooperate with the researcher; (6) pregnant or lactating women who are fertile and are unwilling or unable to take effective contraceptive measures; (7) Any other circumstances deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rates were compared between t;The grade and incidence of oral mucositis after chemotherapy were compared between the two groups;The grade and incidence of leukopenia after chemotherapy were compared between the two groups;Progression-free survival was compared between the two groups;The grade and incidence of neurotoxicity after chemotherapy were compared between the two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| KPS score and NRS score were compared between the two groups;Comparison of chemotherapy completion between the two groups (patients who withdrew due to non-intolerance);The changes of CD4+ T cell count CD8+ T cell count and CD4+/ CD8+ before and after treatment were compared between the two groups;The disease control rate of the two groups was compared;Overall survival was compared between the two groups;The changes of CEA, CA199 and CA724 were compared between the two groups. Index of attenuated efficacy;The score changes of Core Quality of Life Scale (EORTC QLQ-C30) were compared between the two groups;The changes of CD4+ T cell count, CD8+ T cell count and CD4+/ CD8+ before and after treatment were compared between the two groups;The changes of inflammatory factors L-1ß TNF-a VEGF and MMP-9 before and after treatment were compared between the two groups;The grade and incidence of other adverse reactions after chemotherapy were compared between the two groups; | — |
Countries
China
Contacts
Public ContactLi Min
Nanjing Hospital of TCM
Outcome results
None listed