This is an observational clinical trial, aiming to investigate whether the ctDNA dynamics could predict early response to ICIs in patients with advanced-stage cancer. Moreover, conventional tumor markers PD-L1, TMB and MSI are to be investigated for their combined prognostic values in ICI treatment.
18 years and older, both genders.
Patients are diagnosed with stage IV cancer (lung, colorectal, breast, liver, gastric…) and indicated for ICI (first or second line). Concurrent chemotherapy with ICI is allowed.
FFPE/FNA sample is available.
Compliant with treatment protocol.
Patients already started ICI before enrollment.
Consolidation ICI (eg. Durvalumab).
Patients already started chemotherapy before enrollment.
Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
This study population will include female and male, aged 18 and older, who are diagnosed with advanced stage of Non-small cell lung cancer, breast cancer, colorectal cancer, gastric caner and liver caner and indicated for ICI or ICI combined with chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study.
Cohort
Prospective
Not listed
To investigate the relationship between ctDNA dynamics and clinical response to immune checkpoint inhibitors (ICIs) (assessed by RECIST 1.1).
* No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response in case of pseudoprogression
* Correlation between ctDNA dynamics and clinical response * Correlation between RECIST1.1 and clinical response * Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.
To investigate the prognostic value of ctDNA clearance with PFS and OS
* Correlation between ctDNA clearance and PFS * Correlation between ctDNA clearance and OS.
To compare the prognostic values of PD-L1, TMB and MSI in predicting clinical response to ICI, best indicator(s) for ICI response.
* Correlation between PD-L1 and clinical response * Correlation between TMB and clinical response * Correlation between MSI and clinical response.
Click on the lead sponsor to view all of their trials.
