Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

NCT ID: NCT06573424

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Colon Cancer Immunotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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combination group

Patients who have been treated with anlotinib + tislelizumab

Tislelizumab+anlotinib

Intervention Type COMBINATION_PRODUCT

Patients who have been treated with anlotinib + tislelizumabline

control group

Patients who have been treated with anlotinib monotherapy

anlotinib

Intervention Type DRUG

Patients who have been treated with anlotinib monotherapy

Interventions

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Tislelizumab+anlotinib

Patients who have been treated with anlotinib + tislelizumabline

Intervention Type COMBINATION_PRODUCT

anlotinib

Patients who have been treated with anlotinib monotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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fan li

OTHER

Sponsor Role lead

Responsible Party

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fan li

Prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Daping Hospital, Third Military Medical University

Chongqing, , China

Site Status

Countries

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China

Other Identifiers

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TKI+ICIs vs TKI

Identifier Type: -

Identifier Source: org_study_id

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