Colon CancerNCT06573424
Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC
An observational study of Colon Cancer and Immunotherapy, run by fan li at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer, Immunotherapy
- What is being tested?
- Tislelizumab+anlotinib and anlotinib
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced MSS type colorectal cancer between November 2020 and May 2023
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Daping Hospital, Third Military Medical University
Chongqing, 400042
About this study
Official title: 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
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.
- Conditions
- Colon Cancer, Immunotherapy
- Being tested
- Tislelizumab+anlotinib, anlotinib
- Keywords
- Immunotherapy, Multi-omics analysis, tirellizumab, anlotinib
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab+anlotinibCombination product
Patients who have been treated with anlotinib + tislelizumabline
anlotinibDrug
Patients who have been treated with anlotinib monotherapy
| Study group | Role | What they receive |
|---|---|---|
| combination group | Patients who have been treated with anlotinib + tislelizumab Receives: Combination Product: Tislelizumab+anlotinib | |
| control group | Patients who have been treated with anlotinib monotherapy Receives: Drug: anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Measured: 36 months
Secondary outcomes (2)
OS
the time from the beginning of treatmentto death of any cause
Measured: 36 months
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 May 2024
- Primary completion1 Jul 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- fan li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573424
- Sponsor's protocol ID
- TKI+ICIs vs TKI
- Status last verified
- Apr 2025
- First submitted
- 15 Aug 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy AND Multiomic Molecular Characterization of Tirellizumab Combined With Anlotinib in in MSS/pMMR Metastatic Colorectal Cancer: Data From a Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06573424
- Acronym / sponsor ID
- TKI+ICIs vs TKI
- Conditions
- Colon Cancer, Immunotherapy
- Keywords
- Immunotherapy, Multi-omics analysis, tirellizumab, anlotinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- fan liUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination group | – | Combination Product: Tislelizumab+anlotinibPatients who have been treated with anlotinib + tislelizumab |
| control group | – | Drug: anlotinibPatients who have been treated with anlotinib monotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced MSS type colorectal cancer between November 2020 and May 2023
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab+anlotinibPatients who have been treated with anlotinib + tislelizumabline | Combination product | combination group |
| anlotinibPatients who have been treated with anlotinib monotherapy | Drug | control group |
Primary outcome
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)
2 secondary outcomes
OS
Time frame: 36 months
Multiomic molecular characterization of the response to combination immunotherapy
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Immunotherapy, run by fan li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.