Analysis of PD-L1, TMB, CTDNA in Immunotherapy Response Monitoring and Prediction in Advancer Lung Cancer Treatment.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- To investigate the relationship between ctDNA dynamics and clinical response to immune checkpoint inhibitors (ICIs) (assessed by RECIST 1.1).
Study Overview
Brief Summary
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.
Detailed Description
This study is recruiting female and male patients, aged 18 and older:
- Who 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.
- Who have not started ICI before enrollment,
- Compliant with treatment protocol,
- Who have no medical or psychiatric conditions or occupational, responsibilities that may preclude compliance with the protocol,
- Who consented to participate in the study.
Sample collection.
- 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 5 time points: pre-treatment (<10 days before ICI), during ICI every 3 months until 12 months.
- 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples.
As part of the protocol, demographic data, height, weight, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan/ MRI/ PET-CT imaging measured every clinical visit for 24 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 consented to participate in the study.
Exclusion Criteria
- •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.
- •Patients did not agree to participate in the studies.
Outcomes
Primary Outcomes
To investigate the relationship between ctDNA dynamics and clinical response to immune checkpoint inhibitors (ICIs) (assessed by RECIST 1.1).
Time Frame: 24 months
* No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance.
To investigate the prognostic value of ctDNA clearance with PFS and OS
Time Frame: 12-24 months
* Correlation between ctDNA clearance and PFS * Correlation between ctDNA clearance and OS.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response in case of pseudoprogression
Time Frame: 24 months
* 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 compare the prognostic values of PD-L1, TMB and MSI in predicting clinical response to ICI, best indicator(s) for ICI response.
Time Frame: 24 months
* Correlation between PD-L1 and clinical response * Correlation between TMB and clinical response * Correlation between MSI and clinical response.
Secondary Outcomes
No secondary outcomes reported