Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

April 28, 2025 updated by: fan li

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

fan li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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