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OpenTrials
Completed

NCT Number: NCT06573424

Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

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

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daping Hospital, Third Military Medical University

Chongqing, 400042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tislelizumab+anlotinib

Combination Product

Patients who have been treated with anlotinib + tislelizumabline

Anlotinib

Drug

Patients who have been treated with anlotinib monotherapy

Primary outcomes

  1. 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)

Secondary outcomes

  1. OS

    Time frame: 36 months

    the time from the beginning of treatmentto death of any cause

  2. 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

Sponsors and collaborators

Lead sponsor

fan li

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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