Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

Completed

• Conditions: Colon Cancer; Immunotherapy
• Interventions: Combination Product: Tislelizumab+anlotinib; Drug: anlotinib

• Registration Number: NCT06573424
• Lead Sponsor: fan li

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.

Study Timeline

• Study Start: 2024-05-01
• Primary Completion: 2024-07-01
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-24
• Study First Posted: 2024-08-27
• Study Completion: 2024-10-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
combination group	Tislelizumab+anlotinib	Patients who have been treated with anlotinib + tislelizumab
control group	anlotinib	Patients who have been treated with anlotinib monotherapy

Primary Outcome Measures

Name	Time	Method
PFS	36 months	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

Secondary Outcome Measures

Name	Time	Method
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
OS	36 months	the time from the beginning of treatmentto death of any cause

Trial Locations

Locations (1)

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, China