Advanced MSS colorectal cancer
Conditions
Interventions
PD-1 inhibitors+Anti-angiogenesis targeting drugs+Shenqiyichang Granule:Shenqi Yichang granule was given on the 1st day of the 1st cycle of immune targeted therapy, and was used continuously for 6 cyc
Sponsors
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)They were aged 18 to 75 years old 2)They had histologically confirmed unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma (excluding mixed adenosquamous carcinoma and other pathological types) 3)with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors v.1.1 (RECIST 1.1). 4)They had tumor tissues identified as proficient mismatch repair (pMMR), microsatellite instability-low or microsatellite stability (MSS). 5)They had progression beyond or intolerable to at least two lines of standard systematic therapy. 6)the KPS is above 60, and the expected survival time is >6 months; 7) No serious heart, liver, kidney or hematopoietic system damage 8)They were able to provide written informedconsent and could understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1)previous receipt of HDACi, PD-1 antibody or PD-L1 antibody 2) patients with severe heart, liver, and kidney diseases and severe dysfunction; 3)active or suspected autoimmune disease within the last 2 years; 4)interstitial lung disease requiring corticosteroids treatment; 5)acute or chronic active hepatitis B or hepatitis C; 6) a known history of HIV infection or syphilis infection; 7) uncontrolled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg after medication); 8)female patients who are pregnant or lactating; 9)patients who were participating in other drug trials or participated in other drug trials with an interval of 3 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Median progression-free survival at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate; disease control rate;Quality of life;Incidence of fever;Incidence of rash;Antibiotic utilization rate; | — |
Countries
China
Contacts
Public ContactHu CanHong
Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Outcome results
None listed