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Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

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Status

Completed

Conditions

Immunotherapy
Colon Cancer

Treatments

Drug: anlotinib
Combination Product: Tislelizumab+anlotinib

Study type

Observational

Funder types

Other

Identifiers

NCT06573424
TKI+ICIs vs TKI

Details and patient eligibility

About

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

Full 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.

Enrollment

124 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

124 participants in 2 patient groups

combination group
Description:
Patients who have been treated with anlotinib + tislelizumab
Treatment:
Combination Product: Tislelizumab+anlotinib
control group
Description:
Patients who have been treated with anlotinib monotherapy
Treatment:
Drug: anlotinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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