Advanced colorectal cancer
Conditions
Interventions
Treatment group:Xianglian Pills are 1 bag each time, 2 times a day. Immunotherapy (PD-1 checkpoint inhibitors: carilizumab, sintilumab, etc.). There is a course of treatment every 21 days, and there a
Control group:The control group was orally administered granules at 1/10 of the original dose of Xianglian Pills, and other treatment options were the same as those in the treatment group. Every 21 da
Sponsors
Shanghai TCM-Intergrated Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with advanced MSS/pMMR colorectal cancer who meet the diagnostic criteria for colorectal cancer, have a clear diagnosis through pathological examination, TNM stage IV, and are not suitable for local treatment such as radical resection, radiotherapy, and radio frequency; 2) Patients who have received first-line and second-line treatment for advanced colorectal cancer and are assessed as progressing in efficacy; 3) Patients receiving PD-1 monoclonal antibody; 4) No antibiotics, systemic corticosteroids (or prednisone doses less than 10mg/day) or other immunosuppressants were used within 1 month before enrollment; 5) No inflammatory bowel disease, radiation enteritis, rheumatic immunity and other diseases; 6) No other serious complications; 7) Age 18-80 years old, male or female; 8) KPS score =60 points, estimated survival period =3 months.
Exclusion criteria
Exclusion criteria: 1) Those with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, as well as mental illness; 2) Poor compliance and incomplete data during clinical research; 3) The diagnosis is unclear; 4) Subjects who did not implement the provisions of this experimental protocol; 5) Subjects whose observation items are incomplete and cannot evaluate the test effect and side effects; 6) Those who have participated in other clinical trials in the past 3 months; 7) Patients who are pregnant or breastfeeding; 8) During the medication process, those who suffer from other diseases due to non-drug factors and cannot continue to complete treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome score;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal barrier;Intestinal flora;Inflammatory cytokines;T cell subsets;KPS score;ECOG score; | — |
Countries
China
Contacts
Public ContactYi Zhong
Shanghai TCM-Intergrated Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China
Outcome results
None listed