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CompletedNCT06573424Updated May 1, 2025

Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

An observational study in Colon Cancer and Immunotherapy, sponsored by fan li. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by fan li · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
124
Ages
18 Years to 70 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Colon Cancer
  • Immunotherapy

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Keywords

  • Immunotherapy
  • Multi-omics analysis
  • tirellizumab
  • anlotinib
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 124 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

fan li is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
124 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • combination group

    Patients who have been treated with anlotinib + tislelizumab

    Combination Product: Tislelizumab+anlotinib

  • control group

    Patients who have been treated with anlotinib monotherapy

    Drug: anlotinib

Interventions

  • Combination productTislelizumab+anlotinib

    Patients who have been treated with anlotinib + tislelizumabline

  • Druganlotinib

    Patients who have been treated with anlotinib monotherapy

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What researchers measure

Primary outcomes

  1. PFS

    Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

    Time frame: 36 months

Secondary outcomes

  1. OS

    the time from the beginning of treatmentto death of any cause

    Time frame: 36 months

  2. 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

    Time frame: 36 months

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Study locations

1 site
  • Daping Hospital, Third Military Medical University
    Chongqing, 400042, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06573424
Lead sponsor
fan li
Responsible party
fan li (Prof, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Sponsor-investigator
First posted
Aug 27, 2024
Start date
May 1, 2024
Primary completion
Jul 1, 2024
Completion
Oct 31, 2024
Last update
May 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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