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Trial Title:
Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC
NCT ID:
NCT06573424
Condition:
Colon Cancer
Immunotherapy
Conditions: Official terms:
Colonic Neoplasms
Tislelizumab
Conditions: Keywords:
Immunotherapy
Multi-omics analysis
tirellizumab
anlotinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Combination Product
Intervention name:
Tislelizumab+anlotinib
Description:
Patients who have been treated with anlotinib + tislelizumabline
Arm group label:
combination group
Intervention type:
Drug
Intervention name:
anlotinib
Description:
Patients who have been treated with anlotinib monotherapy
Arm group label:
control group
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.
Criteria for eligibility:
Study pop:
Patients with advanced MSS type colorectal cancer between November 2020 and May 2023
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Daping Hospital, Third Military Medical University
Address:
City:
Chongqing
Zip:
400042
Country:
China
Status:
Recruiting
Contact:
Last name:
fan li, PhD
Phone:
+86 023 68757958
Email:
levinecq@163.com
Start date:
May 1, 2024
Completion date:
October 31, 2024
Lead sponsor:
Agency:
fan li
Agency class:
Other
Source:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06573424
