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Trial Title:
A Biomarker Exploratory Study of Dual Blockade of PD1/PDL1 and CTLA4 and Anti-angiogenic Therapy
NCT ID:
NCT06549907
Condition:
MSS Metastatic Colorectal Cancers
MSI Solid Tumors Refractory to PD1/PDL1 Antibody Monotherapy
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Multi-omics testing
Description:
Samples include tissue, blood, urine and stool, and multi-omics approaches include
single-cell sequencing, spatial transcriptome sequencing, macro transcriptome sequencing,
whole exome sequencing, microproteomics, immunohistochemistry, and multiplex fluorescence
immunohistochemistry.
Arm group label:
Exploratory group
Intervention type:
Other
Intervention name:
MRI
Description:
MRI will be conducted to investigate image characteristics during treatment
Arm group label:
Exploratory group
Summary:
This study is a single-center prospective exploratory research, aiming to identify
clinical characteristics and biomarkers associated with the therapeutic effects of dual
PD1/PDL1 and CTLA4 blockade plus anti-angiogenic therapy and investigate MR image
characteristics during treatment in patients with MSS metastatic colorectal cancer and
MSI solid tumors resistant to PD-1/PD-L1 antibody monotherapy.
Detailed description:
This study is a single-center prospective exploratory research. Patients with MSS
metastatic colorectal cancer and MSI solid tumors resistant to PD-1/PD-L1 antibody
monotherapy who are treated with dual PD1/PDL1 and CTLA4 blockade combined with
anti-angiogenic therapy in the Department of Gastrointestinal Oncology of Peking
University Cancer Hospital will be enrolled. Their clinical-pathological features and
specimens will be collected at baseline, at each tumor assessment point, and at disease
progression.
This study aims to identify clinical characteristics and biomarkers associated with the
therapeutic effects through multi-omics approaches, and to investigate MR image
characteristics during treatment. Samples include tissue, blood, urine and stool, and
multi-omics approaches include single-cell sequencing, spatial transcriptome sequencing,
macro transcriptome sequencing, whole exome sequencing, microproteomics,
immunohistochemistry, and multiplex fluorescence immunohistochemistry.
Criteria for eligibility:
Study pop:
Patients with MSS metastatic colorectal cancer and MSI solid tumors resistant to
PD-1/PD-L1 antibody monotherapy who are treated with dual PD1/PDL1 and CTLA4 blockade
plus anti-angiogenic therapy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Pathologically confirmed MSS metastatic colorectal cancers or MSI solid tumors
refractory to PD1/PDL1 antibody monotherapy
- Receiving dual blockade of PD1/PDL1 and CTLA4 in combination of anti-angiogenic
treatment with or without other therapies
Exclusion Criteria:
●Having malignancies in non-gastrointestinal system that have not been cured (Lynch
syndrome not included)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jian Li
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenghang Wang
Phone:
18813186790
Email:
zhenghang_wang@bjmu.edu.cn
Contact backup:
Last name:
Ting Xu
Start date:
January 10, 2024
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06549907
