Colon Cancer, Immunotherapy
Conditions
Keywords
Immunotherapy, Multi-omics analysis, tirellizumab, anlotinib
Brief summary
To compare the efficacy and safety of tirellizumab combined with anlotinib in the treatment of mss colorectal cancer. To investigate the effective biomarker of anlotinib combined with tiralizumab
Detailed description
This was a multicenter retrospective cohort study to compare the efficacy of tyrosine kinase inhibitor（TKI） combined with immune checkpoint inhibitors(ICIs) versus tyrosine kinase inhibitor alone in the treatment of advanced MSS colorectal cancer. Patients with MSS CRC who have been confirmed by pathology and have relapsed or failed multiline therapy were included in the study. Patients who had received tirellizumab plus anlotinib were considered the combination group, and those treated with anlotinib were classified as the monotherapy group. The efficacy and safety of the two regimens were compared. At the same time, Whole-exome sequencing and transcriptome sequencing were performed on the patients in the response and non-response groups of the combination group to reveal the characteristics of their microenvironment and search for biomarkers related to response.
Interventions
COMBINATION_PRODUCTTislelizumab+anlotinib
Patients who have been treated with anlotinib + tislelizumabline
DRUGanlotinib
Patients who have been treated with anlotinib monotherapy
Sponsors
fan li
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18-70 years old * Patients with mss colorectal cancer who have been confirmed by pathology and have relapsed or failed multiline therapy * Patients who have been treated with anlotinib monotherapy(12 mg qd, d1-14; 21 days per cycle) or anlotinib(12 mg qd, d1-14; 21 days per cycle)+ tislelizumab(200 mg, once every 3 weeks) * the presence of at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Exclusion criteria
* Patients with other malignant tumors * Prior treatment with antirotinib, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibody or drug that specifically targets T cell co-stimulation or checkpoint pathways * Follow-up was less than 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 36 months | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 36 months | the time from the beginning of treatmentto death of any cause |
| Multiomic molecular characterization of the response to combination immunotherapy | 36 months | Including WES and RNA-seq analysis. using WES(Whole-exome sequencing) to analyse the differences in the mutational profiles between responders and non-responders. RNA-seq was used to reveal pathways and TME feature associated with the response to the combination therapy |
Countries
China
Outcome results
None listed