Clinical trial NCT06573424: Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC
Official title: Efficacy AND Multiomic Molecular Characterization of Tirellizumab Combined With Anlotinib in in MSS/pMMR Metastatic Colorectal Cancer: Data From a Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Immunotherapy
Keywords: Immunotherapy
Multi-omics analysis
tirellizumab
anlotinib
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced MSS type colorectal cancer between November 2020 and May 2023

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.

Eligibility 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

Primary outcomes:
measure: PFS
timeFrame: 36 months
Secondary outcomes:
measure: OS
timeFrame: 36 months
measure: Multiomic molecular characterization of the response to combination immunotherapy
timeFrame: 36 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
Study officials:
References: