RecruitingNCT06227728

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

Analysis of PD-L1, TMB, CTDNA in Immunotherapy Response Monitoring and Prediction in Advancer Lung Cancer Treatment.


Sponsor

Gene Solutions

Enrollment

50 participants

Start Date

Mar 22, 2024

Study Type

OBSERVATIONAL

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

Locations(2)

University of Medicine and Pharmacy at HCMC

Ho Chi Minh City, Hồ Chí Minh, Vietnam

Medical Genetics Institute

Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

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NCT06227728