Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.

Recruiting now

Conditions studied: Non Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, Gastric Cancer, Liver Cancer, Advanced Cancer, Immune Checkpoint Inhibitor

In brief

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.

Key facts

Study ID

NCT06227728

Run by

Gene Solutions

People needed

50

Starts

2024-03-22

Expected to finish

2026-12-31

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Medicine and Pharmacy at HCMC — Ho Chi Minh City, Hồ Chí Minh, Vietnam (enrolling)
• Medical Genetics Institute — Ho Chi Minh City, Vietnam

Full record on ClinicalTrials.gov

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