Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

Efficacy AND Multiomic Molecular Characterization of Tirellizumab Combined With Anlotinib in in MSS/pMMR Metastatic Colorectal Cancer: Data From a Retrospective Multicenter Study

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

Study Overview

• Status: Completed
• Conditions: Colon Cancer; Immunotherapy
• Intervention / Treatment: Combination product: Tislelizumab+anlotinib; Drug: anlotinib

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 Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400042
    • Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with advanced MSS type colorectal cancer between November 2020 and May 2023

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
combination group; Patients who have been treated with anlotinib + tislelizumab	Combination product: Tislelizumab+anlotinib; Patients who have been treated with anlotinib + tislelizumabline
control group; Patients who have been treated with anlotinib monotherapy	Drug: anlotinib; Patients who have been treated with anlotinib monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	the time from the beginning of treatmentto death of any cause	36 months
Multiomic molecular characterization of the response to combination immunotherapy	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	36 months

Collaborators and Investigators

• Sponsor: fan li

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 24, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; anlotinib; Multi-omics analysis; tirellizumab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tislelizumab
• Other Study ID Numbers: TKI+ICIs vs TKI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No